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Transcript of Meeting

of the Pesticide Program Dialogue Committee

July 21 and 22, 1999



Marcia Mulkey, Director Office of  Pesticide Programs

Jim Aidala, Associate Assistant Administrator, OPP, EPA

Frank Sanders,  Director of Antimicrobials Division, OPP

Jim Jones,  Director of the Registration Division, OPP

Janet Anderson,  Director Biopesticides and Pollution Prevention Division, OPP

Anne Lindsay,  Director of Field and External Affairs Division

Dave Lobb,  National Potato Council

George Pavlou,  Director of the Division of Enforcement and Compliance Assistance, EPA Region II

Ray McAllister,  American Crop Protection Assoc.

Phil Benedict

Bob Rosenberg,  National Pest Control Association

Nelson Carrasquillo,  Farm Workers Support Committee

Ken Rosenbaum,  Independent consultant

Beth Marshall,  League of Women Voters

Bill McCormick,  Clorox Company

Jose Amador,  Texas ATM University, Research and Extension Center in Weslaco, TX

Bill Tracy,  National Cotton Council of California

Warren Stickle,  Chemical Producers and Distributors Association

Dan Botts,  Florida Fruit and Vegetable Assoc.

Paula Paul

Sheldon Wagner,  Clinical Toxicology Oregon State U. Steve Balling Del Monte Foods.

Larry Elworth,  Director of 501(c)(3) Center for Partnerships

Carolyn Brickey,  National Campaign for Pesticide Policy Reform

Margie Fehrenbach,  OPP, EPA

Bob Lake,  Food and Drug Administration

Dan Kunkel,  Food Project.

Robert McNally,  Special Review Branch

William Jordan,  OPP

Carol Peterson,  FEAD, OPP


DAY 1 - JULY 21, 1999

MS. MULKEY: It is that time. Greetings to all of you, to all of us. I had expected and typically am able to kick this off by passing the torch to one of our senior leadership team, who would set an appropriate tone for our time together so that we working stiffs, that's all of us around this table today, can get down to it. I have to start today with telling you of the unhappy coincidence that both Susan Wayland and Steve Johnson are dealing with very sick mothers, with the result that neither of them is able to be here or indeed to be in the office at all this week.

And so that is the reason and the only reason why Susan is not here to greet us. Susan asked in particular that I convey the strength of her commitment to the importance of this process, to our engagement with stakeholders, and I do have the remarks she intended to give and will go over them a little bit. I won't presume to give them, but will share with you the thrust of the kind of sentiment she wanted to start us out with.

Jim Aidala will be with us. There are very few obligations that would trump his obligation to be among us, but among those few obligations he had this morning on the Hill, but he is expected to join us shortly. When he is able to do so, we will simply break in our agenda and give him an opportunity to offer some remarks and hear anything that you want to put to him directly at that initial moment, and then he will share as much time with us over the course of the meeting as he can.

So left as I am without their normal and desired opportunity to be your official greeting, I wanted to share a little of the kinds of things Susan wanted us to hear at the outset. As soon as I do that, we will take an opportunity to go around and identify ourselves, because there are at least a few faces new to us. And then we will work through the limited logistics and get right to work, because that is, after all, the reason we spend this time together so we can work through a number of these issues that are important to us.

Susan approached this morning in a bit of a reflective mood, mindful as we all are, that we have a statute that's about to celebrate a key birthday. We are, of course, coming up on that critical third birthday of the Food Quality Protection Act, and it is a good moment for contemplating what we have been struggling with, where we have come, and Susan believes, and I certainly share that perspective, that it's pretty amazing the number of issues that we've taken on and really advanced, whether it be the complex new approaches contemplated by the statute like the additional safety factor for children or the aggregating of exposures from all sources to a single compound, or the identification and working through of compounds that may work by a common mechanism and so forth.

And subsumed within that, of course, are a host of very complicated science questions all of which have to have some kind of approach available to us before we can do the risk assessments, which in turn present us with the special challenges of balancing our need for realism with our need for the kind of speed that is appropriate given the mandate of the statute.

She wanted to affirm with you our belief in both stakeholder involvement, that's, among other folks, all of us, all of you, and in science peer review. It is significant, I think, that today is the second day of a four-day meeting of our Science Advisory Panel, which is itself tackling very complicated science issues ranging from a biological pesticide, which is in a broad sense a category of organisms which includes organisms to which cystic fibrosis patients are particularly sensitive, and so we have very complicated issues involving plant pathology, human pathology, the medical community. That's just one of about four or five critical issues the science advisory panel is convening on this week, and so it goes.

Susan also wanted to highlight our increased partnering with our sister federal agencies. The extraordinary engagement between the EPA and the USDA as a function of any time in the past except for that time when pesticides were logged at USDA of all the issues. So since 1970 the closest and most comprehensive integration of the regulatory function with all the range of pesticides interests and expertise that exist at and through the Department, as well as, of course, our colleagues at FDA and other parts of HHS involved in these pesticides.

Susan was and is, and I'm pleased to say I think this we can all share, quite optimistic about the directions in which we are going about the increased engagement across interest groups, the increasing dialogue among, for example, growers, industry, and NGO's, not a natural dinner party, and other times, but increasingly a desired coalescence in these times, and the other challenges that relate to the full implementation of this statute and the adjustment to the impacts of its implementation.

Susan closed with a gracious and heartfelt thank you to all of you for your continuing service, and she also included a thank you to the hard work of the Office of Pesticide Programs. So, of course, I would like to acknowledge that part of her remarks and share my own thanks to an organization which is performing at a level of production, productivity and complexity which is really daunting to contemplate.

So with that, I'll add my own largely logistic remarks after we introduce ourselves to each other. Let me start by passing my baton to one of our senior leadership team that some of you know well, but others of you may be new to Frank Sanders.

MR. SANDERS: My name is Frank Sanders. I'm Director of the Antimicrobials Division.

MR. JONES: Good morning. I'm Jim Jones. I'm the Director of the Registration Division in OPP.

MS. ANDERSON: Janet Anderson, Director of the Biopesticides and Pollution Prevention Division.

MS. LINDSAY: Anne Lindsay, Field and External Affairs Division.

MR. LOBB: I'm Dave Lobb with the National Potato Council. I'm sitting in for Dean Zulegar.

MR. PAVLOU: George Pavlou, Director of the Division of Enforcement and Compliance Assistance in EPA Region II.

MR. McALLISTER: I'm Raymond McAllister sitting in today for Jay Vroom of the American Crop Protection Association.

MR. BENEDICT: Phil Benedict from Vermont Department of Agriculture representing States.

MR. ROSENBERG: Bob Rosenberg, National Pest Control Association.

MR. CARRASQUILLO: Nelson Carrasquillo from the Farm Workers Support Committee.

MR. ROSENBAUM: I'm Ken Rosenbaum. I'm an independent consultant.

MS. MARSHALL: Beth Marshall from the League of Women Voters of the United States.

MR. MCCORMICK: Bill McCormick, Clorox Company.

MR. AMADOR: Jose Amador, Texas AME University, Research and Extension Center in Weslaco.

MR. TRACY: Good morning. I'm Bill Tracy. I'm a producer member of the National Cotton Council of California.

MR. STICKLE: Good morning. I'm Warren Stickle. I'm with the Chemical Producers and Distributors Association.

MR. BOTTS: Dan Botts, Florida Fruit and Vegetable Association.

MS. PAUL: Paula Paul, Agrero.

MR. WAGNER: I'm Sheldon Wagner, Clinical Toxicology, Oregon State University.

MR. BALLING: Steve Balling, Del Monte Foods.

MR. ELWORTH: Larry Elworth, Director of newly formed 501(c)(3) Center for Ag Partnerships.

MS. BRICKEY: Carolyn Brickey, National Campaign for Pesticide Policy Reform.

MS. FEHRENBACH: Margie Fehrenbach, I'm designated federal official, and I work in the Office of Pesticide Programs.

MR. LAKE: Bob Lake, Food and Drug Administration.

MR. KUNKEL: Dan Kunkel, IR-4 Project.

MS. MULKEY: Well, greetings to all of you. A special double welcome to Warren Stickle, who is our newest member. The other new faces you see as they explained are sitting in for other members, although George is here as part of our lead region. This is the first time I think we have George with us, too.

We know what matters to you in terms of making this meeting as meaningful as it is. Knowing that and delivering on it are sometimes a little difficult. For example, we know that you like to get materials ahead of time, and we did try, but there is quite a bit of materials added today, and we hope that at least you will find the materials more useful than if we hadn't provided them at all. We will work on that, but we're hopeful that they will be accessible to you in a way that will make your participation meaningful.

We also know that this is an advisory committee, and "we ain't learning nothing" when we're talking, and we're trying very hard to limit our presentations so that there is an opportunity to use them simply to frame up your contribution to our work, and we welcome feed back if we get a little awry on that. Some of these topics are little bit more talking headsy than others, but we're trying very hard to limit what we present to simply what we think will allow us to have a full and workable discussion.

Margie, do you want to add anything else in terms of logistics or rules of the game, and we'll get right to work.

MS. FEHRENBACH: Just that all of the background materials and any statements that are made are going to be placed in our docket, and we also do summaries of these meetings and put them up on our web site. Public comment periods are today at five and tomorrow around noon. And if any PPDC members did not bring the materials that we sent in advance, let me know. We have extra copies of them, and for the public attending, all of the materials are out on the display table.

MS. MULKEY: Very good. Well, shall we get to work. Does anybody have any opening questions, remarks, concerns before we get down to the first topic?

(No response.)

MS. MULKEY: Okay. Good. Well, we are attempting to focus on the registration side of our house with a little special emphasis on the IR-4 program, the program managed by USDA, which provides the means by which minor uses can get the kind of research, support, and in our case then the kind of registration attention that adapts to the reality that minor uses do not always carry the same economic clout as the higher volume uses.

So without further ado, Jim, Frank, and Dan on behalf of IR-4 are going to try to tag team a little bit here and work us through this material.

MR. JONES: Okay. We actually do have the registration team, senior team in OPP right at this corner of the table. Frank is Director of Antimicrobials, and Janet the Biopesticides Pollution Prevention Division, and myself the Registration Division, which handles these synthetic products.

I'm going to talk about the synthetic compounds, and Janet is going to join me during this presentation and then Frank will talk a little about the antimicrobials program, and Dan will follow up with some discussions about IR-4.

The genesis actually of this discussion was from an earlier PPDC meeting where many of you asked for a little better handle on some of the resource issues. Basically the registration resources -- when I'm talking about registration right now, I'm talking about all registration in OPP. There are 270 FTE's in FY99, a little increase over last year, and about $4 million in contract dollars. These resources are split between our three divisions.

MS. MULKEY: Those are direct resources, Jim, that doesn't include your share of overhead like IRSD, or does it?

MR. JONES: It does. Of OPP's 850-odd FTE's, these include the resources allocated to registration. These are the numbers you see in the budget presently. And this is basically how the FTE's are divided.

The Antimicrobials Division has about 25 FTE's dedicated to registration. Janet's division, Biopesticides and Pollution Prevention Division has 40 FTE's for registration. Then there are for conventional chemical registration about 167 FTE's. Those FTE's are divided among the Registration Division, the Health Effects Division, the Environmental Fate & Effects Division, the Biological Economic Analysis Division. Unlike BPPD and AD, the registration of synthetic chemicals are handled in a matrix. Multiple organizations participate in the review and the regulatory management. Then the program management and support is about 39 FTE's.

For contracts, we have $4 million in contracts allocated to registration. This year, the deputy administrator following something that was done last year as well, we sort of hope it becomes an annual event, pulled together about $1 million in contract money. And that money was dedicated to the registration of synthetic non-antimicrobial pesticides, RD type of chemicals focused on reduced-risk pesticides -- a total contract allocation of about $5 million. Of that $5 million is basically split about $2 million for Registration Division. Frank has close to $2.5 million, and Janet has a very small share of that.

One of my favorite charts, the historical comparison of active ingredient registrations under Section 3 of FIFRA. There is always debate about productivity, going up, going down. The chart is a little busy, however, if you spend a little time with it at your leisure, you'll see that basically after 1992 we have about doubled our new active ingredient registrations as a program.

I think sort of the creation of BPPD and the subsequent creation of AD have significantly added to that. That has made us much more productive in antimicrobials and BPPD. As it relates to the registration of synthetics non-antimicrobials, we've increased our productivity 50 percent. If you look at the five years from 1988 to 1992 and compare that with the six years subsequent, you'll see about a 50 percent increase in Registration Division outputs, and at the end of the day you're seeing a virtual doubling of programmatic registration of new active ingredients.

For the conventionals, we break down between a conventional regular and a conventional safer. Safer being the program we talked about many times, and we'll talk about more today.

Some of the details of conventional chemical registration program activities. Last year we registered 13 new active ingredients. This year we have registered nine. Our goal is 13 again this year. As it relates to tolerances, new uses, section 18s, we're still seeing a large heavy volume of Section 18's. Pre-FQPA we saw in the range of 350, 400. Post-FQPA it's been over 500.

Our average turn around time last year being 56 days. Our goal is 50 days. After the third quarter of this year, June 30th, we were at 59 days. We're very confident, at the end of the year, which is September 30th for us, that we're going to be below 56 days.

There are also two categories here, which many of you are probably not familiar with, but a couple of you are probably are very familiar with it, have to do with the amendments and the me-too products. A huge volume in terms of me-too's last year -- 621 completions. This year so far, 284. We have eliminated our fast track backlogs, which is a statutory 90-day turnaround time for me-too applications.

Another category is inerts. Food use inerts, we cleared 14 last year. So far this year, we've done three. I think we'll come close to 14 this year. Non-food use inerts, we have approved 71 so far this year. High volume of both submission and completion.

Janet is going to speak to you about biopesticide registration.

MS. ANDERSON: Why do we get such a tiny budget? Well, there isn't really a good reason. What we do in biopesticides is the biochemicals and natural occurring compounds, both the genetically engineered and the naturally occurring microorganisms and plant pesticides (products that are produced by plants as genetically).

And there are only a very few people we have found in the outside world to help us in review of biochemicals. So that's where half the money goes.

Looking at this, and you may want to compare it to the synthetic chemicals to have an idea of the difference. Last year we did 12 new active ingredients. So far this year 10, and we anticipate that we will probably make 13 also. You will note that the other numbers generally are smaller for us. We have done ten tolerance exemptions. We've added an awful lot of new uses. In fact, we may rival you for new uses this year. We had a registrant who decided for a microorganism to list every crop it could possibly add, and each one of them ended up counting. So it's kind of a fluke this year, but it just was a tremendous number that a couple of registrants chose to put on their product, and that's their choice.

There are some experimental use permits that we have going, including some genetically engineered crops. We believe this is important, because this is a pipeline for the future. More 24(c)'s than usual, and again, we have me too registrations and the fast-track amendments and just one so far of a notification for a field trial for a new genetically engineered microorganism.

Overall the biopesticide program has about 180 active ingredients that we monitor, and that's a little over a fourth of all the active ingredients actually registered with EPA. And so the division has a lot of active ingredients but not as many products as you will find in registration division.

MR. JONES: Janet doesn't have this chart, because she doesn't run a backlog like we do. Basically she gets 13 a year, she does 13 a year. On the other hand, we run a rather significant backlog as it relates to new active ingredients and new uses.

There are currently 48 active ingredients pending with the agency right now. About eight of those are actually in this year's work plan that have not been registered. Of that 48, it's a high number, but there are some features of it I think are interesting. Ten of them are for import tolerance only. Eleven are reduced risk or OP alternatives. So you'll very likely see them on next year's work plan. There is actually an OP in that group. It's kind of an interesting collection. Six of them are total non-food use pesticides. 455 new uses pending that involve over 100 active ingredients and 10 FEUP's.

So to summarize what was in the work plan for FY99, which, by the way, we do publish on the internet if you really want to track how we're doing. If you go into OPP's web site and just basically look under RD work plan, you can see what we committed to in terms of new active ingredients and new uses by the quarter. We made them by quarter, and then the status of them. Basically, we had 20 active ingredient candidates. Our goal is to register 13 of them. We're pretty much on track for that.

We had 50-odd new use candidates. We are very likely to far exceed that. I think we'll have about 100 or 110.

Then the ever controversial priority system everybody loves to talk about. When you have more work than you can do in a given year, you then decide what you're going to do first. We have over the last four years had a very public process to help us figure out what we should do first -- or what order we should do our work in and every time we propose a change, we go public with a stakeholder process involving the Federal Register and other discussion dialogue about the change.

Right now this is the order in which we will do work in front of us as it relates to new chemicals and new uses of existing chemicals. Methyl Bromide alternatives. There are very few of those that have been brought to us. So they don't really take up that much of our work right now. OP alternatives, which are reduced risk candidates, would be the next one, and there are a fair number of those. Other reduced risk candidates would be next, a fair number of those as well. This year we may register more reduced risk candidates than non-reduced risk.

Non-reduced risk candidates we think they are OP alternatives. There are a rather large numbers of those. That, by itself, may not meet our reduced risk criteria, but it's clearly an OP alternative. USDA/EPA vulnerable crop/pest combinations, this is something that was published in the Federal Register several years ago by USDA. IR-4 petitions get high priority. Actually we have an agreement with IR-4 that we will attempt to work on all of their petitions, which you'll hear they are wrapping up some budgeting for some data a few years ago. Minor crop uses submitted by the registrants, trade irritants, and then other registrants identified prior. I will note that everything in the list has to be supported by a manufacturer. We are not working on compounds that are not submitted by manufacturers.

And that is it for synthetic and biological pesticides.

MR. SANDERS: Good morning. Again, my name is Frank Sanders, and I'm pleased to be here. I don't get an opportunity to visit with the PPDC that often, but when I do, I always enjoy it. The antimicrobial division has a good story to tell. It's not a perfect story, but hopefully one day it will be. I do want to tell you some of the things that we have accomplished during the course of 1999.

We have not finished that year, obviously, but as most of you know, we start out with a work plan, and our work plan lays out the targets we want to meet during that given year. In the case of old chemicals and fast track and non-fast track, we started out with a target. We have exceeded that target. We had 143 percent of what we were obligated to do. We were 298 percent over our old chemical non-fast track actions, and for many fast-track amendments, we have about 173 percent. And amendments non-fast track, we have 234 percent.

That in some cases -- notifications we have about 93 percent, and we still have a ways to go before the end of the fiscal year. We expect to be about 100 percent at that point. There are areas where we certainly have not gotten the number of actions in that we had anticipated, for example, new uses we had anticipated to get somewhere in the neighborhood of 13. We've only got five or six new uses in. So we're below that target. We're at 38 percent. So it's not a perfect story by any means, and we're still working hard to reach that level.

We also have been successful in achieving a 98 percent reduction in our backlog. As most of you know, when Antimicrobials Division was first formed, we had a backlog of somewhere in the neighborhood of 300 or 400 actions. We reduced that backlog by about 98 percent, essentially zero, and we intend to continue to work to achieve 100 percent elimination of backlog.

You also may know that on August 3rd, 1996, the FQPA was enacted, and had specific requirements for antimicrobials division. One of those requirements was that we have targets that we have to meet, and if we don't meet those targets in terms of completion of registration actions, then we're subject to judicial review, and the lawyers around the table probably know better what that means than I. I don't want to know what it means; therefore, I cannot miss any FQPA deadlines, and I have not. We have not missed any of our FQPA deadlines, and that, I believe, is a good thing. That way I don't have to find out what judicial review really means.

Rulemaking -- we are also in the process of completing a procedural rule 152. I think it will probably be issued sometime late fall or early December. We are working very hard to get that done and with the help of a lot of folks in feed. We anticipate completing our PR notice on treated FEAD articles before the end of the summer. That may be optimistic, but we're going to try. We've also issued guidance on sterilants, PR notice that was issued 1998.

We're in the process of working with FDA, CDA, USDA on foodborne infections, trying to find ways to better protect the American public as it relates to foodborne illnesses.

We're also in the process of developing test models to better assess exposure under certain scenarios, particularly in the case where certain data are missing, and we're using a Swim model and a cell migration model. Let me turn to some of our challenges for the future. Again, I want to emphasize how important it is for AD to work with industry as well as other federal agencies in developing methods and protocols for treated articles and other cutting issues. We believe that it's extremely important to continue the dialogue with industry and try to find ways to develop these protocols.

We also have a PR notice that I would like to say is coming out very shortly that has to do with the surrogate HBV test protocols. We plan an FR notice to explain the process with submitting data using a duck as a surrogate. As many of you know, the previous test was conducted on chimpanzees, and we have a real problem with that, and it's very expensive. Not only that, there are some ethical issues surrounding the chimpanzee studies.

Reregistration, our goal is about 40 REDs by year 2002. That's an ambitious goal for AD, but we believe it's doable, and we're going to work to make sure that happens. And I'm not going to spend an awful lot more time talking about some of the things we'd like to do and some of the things we have accomplished. The bottom line is that AD is working hard to do a good job, and if industry has questions, I'd certainly be more than happy to take those questions.

AD has stakeholders meetings that occur at least three or four times a year, and so we do meet with our group of folks similar to PPDC, and we believe that meeting is very productive. Thank you.

MR. KUNKEL: Hello. My name is Dan Kunkel from the IR-4 project. I just want to thank you all for inviting us here to the committee meeting. I just want to go over a few background things for the IR-4 project, our objectives, strategic plans, and some of our new partnership initiatives, and then get into some of our registration objectives that we have.

The IR-4 project is funded through the USDA CSREES, through grant funds every year, but our objective is to develop data to support registrations on minor crops, including food and ornamental crops. And then, of course, to maintain existing registrations through reregistration data requirements.

We also have a biopesticide program. So our other objective is to further develop registration of biological pesticides as well, and some of our new initiatives is to expedite the development of new pest control technologies for minor crops.

Our strategic plan for minor crop minor uses is to promote the reduced risk pesticides as much as possible, develop risk mitigation measures for existing registered compounds, assist with registration of biologically based pest control products, and register and maintain products essential to IPM programs. Not only in IPM programs as it applies to threshold levels, but also in use and reduced risk compounds and risk mitigation measures.

We develop partnerships with key organizations. We've always had partnerships with grassroots growers, commodity groups, but also further our partnerships with some of the major chemical companies and the Environmental Protection Agency as well.

And then to expand our new technology team initiatives, and this is what I'll get to in a moment here, but to basically pursue any new pesticides that are being developed with the companies to try to register them concurrently.

Just to give you a little idea of some of our -- we use reduced risk with capital letters and also with small letters, lower risk alternatives. But just to give you some idea of the work we've been doing with what we call lower risk or reduced risk compounds. Before FQPA was passed, we had 20 studies involving lower risk compounds. In '97 we went up to 45 studies, and our program has been generally about 150 studies a year. So last year we had 78 studies -- about half of our program -- and in 1999, about two-thirds of our program, 90 studies, are with the lower risk or reduced risk compounds.

Some of our partnership initiatives are with the Environmental Protection Agency. We've been having quarterly meetings with Jim and Margaret Stasikowski with Health Effects Division, Pat Cimino and Hoyt Jamerson with the Minor Use Team, but we're trying to work smarter. And how are we going to do this? We're going to set up a three-year work plan so that we can use our allocations the most wisely. So we have a three-year work plan. What we're trying to do with this is just to try to maximize our slots and put as many projects for a single AI into a single slot.

Everybody is always asking how many slots does IR-4 have? Well, the answer to that question I usually give is we don't have any. What we do is submit our packages, and then the Environmental Protection Agency decides where they want to put it in. We have a priority slot, but we also fit into methyl bromide replacements, reduced risk OP replacements -- our petitions fall into all those categories. So we submit them.

Of course we have objectives and priorities that we want to see projects go through first, and we let the agency know that, but once they go into the agency, the agency looks at them in the manner that they want to review.

Expand minor crop tolerances for targeted safer reduced compounds, improve IR-4 petition format. Not that we really have a problem with our format in the past, but what we did is redo our petitions in a format where the agency can review it using the same format that they used to review petitions. This should save them about two to three months in review time by us using their format in our petitions.

Residue data extrapolation, try to use our data as wisely as possible, maybe extrapolate from some major crops to some minor crops, maybe reduce some of the requirements that we have to provide for some of the ultra minor crops.

Streamline minor crop reduce risk justification. Some of the product performance market basket surveys that's required under reduced risk was a big burden for IR-4 to provide that data to get reduced risk status for some of our uses. We've worked with the agency. They've streamlined it for us, and now we can extend that to some of the minor use growers that they can say they are using reduced risk compounds as well.

Multi-year Section 18's. The agency was using a lot of their resources to review section 18's. We've worked with that and showed them some of the ones we thought would be multiple years, and we've seen a few multiple year section 18's get posted this year. And then working with our global registrations at North American Free Trade and EU data, trying to share some of that data to reduce some of the cost of data generation.

Partnership initiatives of the crop protection industry. Again, we just want to get in there and pursue some of the newest chemistries available and try to work with the companies to develop registrations on minor crops concurrently with their objectives.

We reduced the streamline minor crop reduced risk justifications. Targeted minor crops were again extrapolating data to the ultra minor crops, and there is a lot of overlap here with some of our initiatives with the Environmental Protection Agency, lower registrations, and they also invited us to sit on some of their round table discussions as well.

Moving into IR-4 registration priorities. Just to start off here, IR-4 for 1999 research initiated a new policy. From the time they initiate a study to submission to EPA would be 30 months. So anything we start in 1999 we plan to submit by 2001.

Just to give some examples of our priorities, spinosad, it's a reduced risk compound a potential OP replacement. IR-4 started trials in '97, we submitted the data in '98, and it was registered for use this year. That's what we want to have as a goal for all of our studies. Tebufenozide we did research in 1996 mostly on blueberries, cranberries, canola, mint, turnips, most of these compounds are labeled for use this year.

Again, this is us working with the agency to get these registrations for OP replacements in a timely manner. Bifrenthrin on lima beans; several years of Section 18, this was part of Del Monte's program for IPM. We submitted the package in February of this year. The agency reviewed it, and it was registered for use for this summer.

One of our other compounds, imocropalid, another OP replacement we see some registrations coming out, and I'll get into the specific numbers in a little bit, but I just want to show you that some of these -- we have other petitions submitted to the agency, but the agency used these as their priority after we submitted them. They wanted some multi replacements. We provided them the data, and they registered it in a timely manner.

Some of the other reduced risk compounds that we're working with fungicides, Fludioxonil, et cetera, we've seen a lot of section 18's for some of these compounds. We're expecting registrations for these some time in the near future.

IR-4 routinely provides a lot of data to support Section 18 registrations, but now these are in our queue for EPA review. Either they are finishing it this year in 1999, or they plan to review these projects in their fiscal year 2000 review plan. But you can see there is a wide range of compounds here. We're even getting out some of the reduced risk OP replacements and getting into some of the other compounds where we've seen multi year Section 18's.

Just a few more Section 18's. We're really going across the board, herbicides, fungicides, insecticides, and, again, many of these were under multi-year Section 18's.

For fiscal year 1999 EPA had what we call 35 IR-4 slots. These are being reviewed on schedule, and some of these are even being reviewed ahead of schedule, like the Bifenthrin on lima beans. We were expecting that to get reviewed in the fourth quarter. They finished it, and it got registered by the end of the third quarter. So we see that the agency is holding up to their scheduling procedures.

Fiscal year 2000 starts in October. We have 130 slots that we're looking at. This is what we're shooting for. This is what IR-4 is shooting for. This is what EPA is shooting for. 130 petitions we plan to submit.

We're already planning for first quarter. IR-4 has about 35 to 50 petitions already at the agency that's going out for review for first quarter of 2000. We would like to hang onto this 130, 150 slots, because the number of studies we conduct a year is about 150 studies.

So we have seen a big turn around with the number of registration priorities, IR-4 priorities that are being reviewed, and I think this is partly in response to the FQPA in getting some of these reduced risk compounds registered.

We're also getting a lot of support. The IR-4 has finally realized the funding of about $9 million through a special research grant, and then we have hatch funds and ARS companion project made up with some private funding as well and our budget has been $12.5 million in 1998, and it looks like it will be that for 1999 as well. So we've stacked up. We have about eight study directors that make up our registration group, and we have three quality assurance officers. We're stacked up to continue providing the agency with about 150 packages a year.

MS. MULKEY: Well, we hope and expect that you'll be interested in engaging on this material. This presentation was largely in response to specific requests from one or more of you, but before we go to that, I want to take a minute to greet and welcome Keith Pitts, who is our senior representative from USDA on this committee. Most of you know that he is director for the Deputy Secretary, and I'm sure that he wants to say a few things, and then we'll say hi to the folks who joined us, and get on with the discussion.

MR. PITTS: I'll just say good morning everyone, and glad to be here. I'm looking forward to going through the agenda the next couple of days, and just leave it at that.

MS. MULKEY: That was brief. I noticed that Paula, Shelley, and Jacqueline came in since we --


MS. MULKEY: But in any event, you're all welcome. Did I miss anybody else who has joined us since we all -- Carolyn. Maybe I got Paula and Carolyn mixed up. In any event, you are all welcome.

Let's just go straight into this set of topics.

(End of tape.)

MR. ROSENBAUM: Can you tell us how you track the quality of registrations and what the trends are there, and what you're doing to improve quality?

MR. JONES: We have actually since FQPA in the Office of Pesticide Programs and largely due to the efforts of the Health Effects Division and the Environmental Fate and Effects Division, dramatically enhanced the peer review process that basically all of their work goes through.

There is hardly a discipline, and I'm not sure that there is a discipline now, and I'm talking now about chemistry, toxicology, ecological fate, ecological effects -- environmental fate or ecological effects, metabolism, all of these disciplines now have peer review committees within the Health Effects Division, and the Environmental Fate and Effects Division. So I feel like in the time that I've been working in registration activities, which crosses the pre-FQPA to the post-FQPA, that the confidence that I have in the work that we've done has increased pretty dramatically.

The other thing that is an anecdotal reference to quality is that we are seeing far few rejected studies from the manufacturers. That's sort of based on some work that began five or six years ago by Pete Caulkins in the Registration Division to reduce rejected studies from the manufacturers.

Another sort of anecdotal piece of information is we're seeing a dramatic increase in the number of reduced risk compounds that are submitted to us. Those compounds are far easier to review. They generally have much preferable profiles both environmentally and from a human health perspective.

MR. ROSENBAUM: That's great. It would be really interesting to see a list of who is on the peer review panels if that would be possible.

MR. JONES: We could do that. They are scientists within our organization.

MS. MULKEY: We do submit a lot of issues to external peer review, too.

MR. ROSENBAUM: It makes me a little uneasy to see so much reliance on easily quantified things like numbers of registrations, and I know that sometimes numbers have a spell that can enchant you, and you lose track of the hard to quantify things like quality, and that's certainly of more interest to some folks than quantity of registrations.

MS. MULKEY: Anne, do you want to add something?

MS. LINDSAY: Just another way to sort of assess quality, and this is an idea on the drawing board. It's not an actuality at this point, but we've been working with our office of enforcement, our regional offices and our state partners to look at the possibility of building what we would call a pesticide field data program, and the concept would be to bring back real world information as pesticides are used, which would come back onto all three of our registration divisions to sort of assess. When we evaluated the data and established the conditions of registration and the labeling requirements, did we do our job right or is something happening in the real world that suggests we need to take a relook in any shape or form.

So it's a concept at this point, but a piece of the quality control that over the next couple of years we'd like to try to put into place.

MR. ROSENBAUM: That sounds like a great idea.

MS. MULKEY: People may want to come back to this. It's obviously a thoughtful subject for worth of some more attention, but we will go ahead and move through, because there is -- the range of issues that this presentation touched on is considerable.

Jose, I'm going to just try to work around so you'll know what we're going to do.

MR. AMADOR: Jim, can we get a copy of your slides. It's not included in the package, is it? Okay. I'd like to get one. I gather from your presentation that the backlog that we have in IR-4 is beginning to work itself out, right?

MS. MULKEY: Why don't you just wait and ask.

MR. AMADOR: It looked like the backlog that we used to have in IR-4 is beginning to work itself out. I mean, the complaint that we heard of first you have FQPA we only had about four or five. Now it seems that things are going back to pretty much normal. Is that a pretty good assessment?

MR. KUNKEL: I would say by the end of fiscal year 2000 if the agency reviews the packages we give them, our backlog would be worked off. We would be pretty much caught up on our backlog.

MR. AMADOR: On one of your slides you said you had 150 studies per year. What are you referring to, that's not field study?


MR. AMADOR: We certainly have more than that when you include the whole United States.

MR. KUNKEL: We conduct 150 studies per year, but they are supported by about 600 field trials.

MR. AMADOR: Okay. So that's the difference between studies and field trial?

MR. KUNKEL: Right, uh-huh.

MR. AMADOR: So that would be the same chemical being tested in two to three different locations?

MR. KUNKEL: Or maybe six, right.

MR. AMADOR: And you never have enough money, but, I mean, the idea that I get is that IR-4 feels good about some of the increase in support of the -- (inaudible) -- as a result of the increased demand of it?

MR. KUNKEL: Yeah, I think the funding that we have now, we certainly feel much better than we did than when we were around six million a year. With the resources we have, we also have about 26 IR-4 field research centers across the country, and about 15 analytical laboratories that we use from time to time. There is about eight that we use all the time, and then our regional offices. $12.5 million we still feel like we're still kind of on the edge of maintaining all of our field research centers and laboratories and regional offices.

So at least we're to the point where we feel like we're maintaining all of that. Every year you'll have, you know, the cost of living increases and the like, but I think we're at a level now where we can get some more accomplishments made with the funding that we have now.

MR. AMADOR: And I'm very glad to hear that you feel the cooperation you get from EPA is very, very good. You seem to be working together very well.

MR. KUNKEL: Yeah, I would say our cooperation with the agency, I've been here eight years, but it's the best that I've ever seen it since I've been working. We really have a synergy going, and we feel like we're going to be able to get a lot accomplished. We've gotten a lot accomplished in 1999, and we feel like we'll get a lot accomplished in the year 2000 as well.

MR. AMADOR: This is great, because this is minor crop, minor uses, and the IR-4 program. It was always felt it was one of the most impacted by the FQPA, but it seems like things are progressing, and I presume Steve is happy about some of the registrations that he had gathered. So that's a big note, and I'm happy to hear that.

MS. MULKEY: Thank you for encouraging us to spotlight this program. It was Jose who suggested we include this. He may not have been the only one who suggested it, but he was certainly forceful in encouraging us and thank you for --

MR. AMADOR: Well, it was one area that we had a lot of complaints and things were not being done. I thought people needed to know that there is a lot being accomplished in the last year or two in the IR-4 program.

MS. MULKEY: All right. Thank you. Warren.

MR. STICKLE: First of all, I'd like to start by commending Frank for his report from AD concerning the backlog on one hand, and then also meeting all the new deadlines under FQPA, especially the fast track, me too and label changes that have been coming in for the last three years.

I wanted to ask Jim a question, because I know when we were looking at the current pending reports in the conventional pesticides, there was a report on the new actives, the new uses, and the EUP's, and I wanted to get perhaps some indication of what the backlog might be for fast track, non-fast track, the me toos and label changes, the ones that have come in since FQPA and wondered where we were on that issue and what steps were being taken to address that.

MR. JONES: Right now for fast track me toos, old chemicals basically, we have no backlog. There wouldn't be any submitted pre-FQPA, because that would clearly be over 90 days, and that was our goal for FY98, and we achieved that. So we do not have a backlog. There may be two or three actions out of the thousand that are submitted a year that are in a backlog right now. Essentially it's a zero backlog for me too old old chemicals.

For fast track amendments our goal in FY99 was to achieve a zero backlog, and for those of you who don't know, this is somewhat of a narrow part of the program. The statute FIFRA requires EPA to review fast track old chemicals me too applications. Basically a chemical that is substantially similar to an already registered pesticide or -- yeah, a me too chemical in 90 days. And we have historically run very large backlogs in our me too program, and in '98 basically for old chemicals we achieved a zero backlog. We were meeting the 90 day time frame and for amendments, fast track amendments, those are amendments that are made by manufacturers that don't require any science review.

This year our goal is to achieve no backlog in that, and we are very close to that. As you know, when I send you quarterly reports on that. We haven't achieved it yet, but we are in striking distance. We've got about a month and a half or two and a half months to go, and we're confident we are going to achieve it.

We have rather large backlogs in the non-fast track arena. Those are non-me too applications that generally involve significant science review, and we are going to try to really start reducing our backlogs in those arenas starting in FY2000.

UNIDENTIFIED MALE SPEAKER: I have a follow-up question on that. Jim, on this FY99 you have a 284 versus 621 for those old fast track and non-fast track and the 1539 versus 25. Are these actions the backlogs

-- I mean, do you have as many backlogs for both of those years, or is this reflective of a slow down or is this reflective of what's in the pipeline?

MR. JONES: It's a reflection of the pipeline. The backlog reduction, when you start to get rid of your backlog, what you're basically then doing is what's being submitted as opposed to doing what is submitted plus all the things are backed up. I actually have --

UNIDENTIFIED MALE SPEAKER: If this was a percentage basis of what you have pending, would that be equivalent or less?

MR. JONES: I can give you -- what I do is every quarter and I send it to Warren and to CSMA a very, I think it's a rather detailed chart that lists the numbers that were submitted by category, the number that were completed by category, the average turn around time, the number pending, and the number of those pending that are backlogged. I think that that would get to your question, and we're just about to do our third quarter '99 one. I'll make sure that you get a copy of that as well.

UNIDENTIFIED MALE SPEAKER: Just as a ball park, does this represent a lower or a higher or about the same percentage?

MR. JONES: We are reducing our pending and our backlog in all of our categories.

MS. MULKEY: And that would translate to a higher percentage if I understood the question correctly.

Thank you. Maybe Shelley will get us a little bit outside of the inside baseball on this, but these issues are very important to those whose business it is to move their labels into modern era.

MS. DAVIS: I wanted to return for a moment to the IR-4 program, and I apologize, and I didn't hear the whole presentation. In reviewing the EPA's most recent risk assessment on azinphos methyl of May of '99, I notice that IR-4 was doing at least three studies with azinphos methyl, and I was very concerned, because that's a very high toxicity chemical to workers. And I was wondering whether, first of all, you're going ahead and finishing those studies, whether there are other toxicity category one, which is the highly acutely toxic pesticides or carcinogenic or teratogenic pesticides that you are testing.

MR. KUNKEL: The only work we're doing with the azinphos methyl is to support reregistration projects. So we're completing any of our reregistration projects so the agency can use that in the reassessments. But we're not really starting any new projects with any organophosphate insecticides. We're kind of standing by if there are any mitigation studies that need to be done, we could schedule those and work on those, but we're really not doing any new work with any organophosphate pesticides.

MS. DAVIS: As a follow up, are there pending projects of other OP's that are tox ones or twos?

MR. KUNKEL: You know, I'd have to look through our data base and what our research plan is with each chemical to tell you for sure. But as far as the insecticides are concerned, I would say no.

You know, most of our work now is with reduced risk compounds. We have a heavy program with methoxyfenozide, amichlorprolid, spinosad. We're basically completing all of our spinosad projects in 1999. Any requests we ever had for spinosad, we're finishing all those projects with our 1999 research. So as far as the insecticide area, I mean, there may be a herbicide or two that may be in the next round of reassessments that we may be doing some work in, but that would be the only projects that I could think of.

MS. DAVIS: Just a final follow up. So is there a coordination between the two agencies on the question of selecting pesticides to test that are the less toxic ones? Is that an issue to be considered when you decide which products to test?

MR. KUNKEL: Yeah, well, first of all we have our strategic plan for moving reduced risk pesticides, lower risk pesticides registrations along as quickly as possible. We start our planning for our 2000 research, our planning will start in August. We have a list -- we break down to a smaller list of projects that we want to do research on, but then we send that list over to the Environmental Protection Agency for ones that would likely be able to get registration.

So we review the list internally according to our strategic plan of moving reduced risk compounds, but we also give the list to the agency and say, okay, here is our list for 2000 research. Is there any possibility these are going to go forward, or is there a problem with some of these compounds that it will not go forward. If they say there is a problem, then we pull it off of our research plan for the next year.

MR. JONES: That's probably the top criteria that we're using as we are working with them on what to pursue from a registration perspective is the safety of the compound.

MS. DAVIS: But that wasn't an issue with Azinphos Methly?

MR. JONES: As it relates to IR-4 working on the defense of a reregistration compound, they are two different parts of the IR-4 work. As it relates to registering new uses, which is what Dan was talking about this morning that I'm referring to. I'm not referring to their work on defending old uses. They are not pursuing new uses without working with us to make sure that the new uses have tox and environmental profiles that we think are going to be appropriate.

MS. DAVIS: But is there some reason that that's not a criteria with regard to reregistration?

MR. JONES: I can't speak to that.

MR. KUNKEL: Most of the reregistration projects we started several years ago in response to FIFRA 88. And the azinphos projects, we're in the process of completing those. We probably started field studies in those in the mid-90's, and now we're just in the process of finishing those, submitting them to the agency in response to FIFRA '88 requirements, and then the agency can review those in their reassessment procedures to see if, you know, the data that we have, which probably would provide them what the actual residues are as opposed to tolerance levels. More recently what the residue levels are.

So really the registration projects, we feel we're finished with those. We're submitting a few projects, like the azinphos methyl, just a few projects we have left. I think we only have one more left to submit, but really that's for registration requirements. So all of our new research, again, we're moving with our strategic plan for reduced risk compounds. So the azinphos methyl is really strictly just to provide data requirements as required in FIFRA 88.

MS. MULKEY: Thank you. Paula?

MS. PAUL: Thank you. My question really goes back to Jim, I think, and first commending the agency for your performance. I think the last several years have been, and we all acknowledge, difficult with a major new law, staffing, and probably inadequate resources to do the job that you've been asked to do. So we do appreciate that things have been moving along. I wanted to make a point, and I had one question. The backlog is probably a little inaccurate in the sense that companies because of the priority system are probably not necessarily submitting petitions if there isn't a reasonable expectation that it's going to be reviewed. So obviously, you know, there have been ongoing discussions on how we can help provide the resources to the agency, and I just wanted to ask you what you thought the impact of the agency's proposed tolerance fees would be on the backlog and the resources and whether you think it would open, you know, what your goals are toward new chemical registrations -- time from submission to approval.

MR. JONES: The tolerance fee rule you're referring to?

MS. PAUL: Well, the tolerance fee rule and you might also address fee for services if you want to, but I guess the tolerance fee is out there.

MR. JONES: We're going to talk a little this morning about both of those. Actually in the next session, but in brief, I don't think the tolerance fee rule will speed up the registration of synthetic non-antimicrobial compounds.

I will say, Paula, in the first point that you make that I've heard that for several years that the priority system constrains what can be submitted by manufacturers. So I've spent some time looking at what's submitted and talking to manufacturers, and I think that we may want to all get together to talk about that.

My experience has been that when a company is ready with a new active, they will switch it with something that they have put in the priority system, because it's a higher priority for them, and we allow that kind of switching. So I'm not sure there is too much sitting in company rooms ready to come in. But I think it's probably good for us to have that conversation as a group to make sure people know that they can switch their priorities and if they are sitting on a new active ingredient --

MS. PAUL: If they have priority slots to switch it to.

MR. JONES: Everyone right now -- I don't think there is a company that doesn't have a priority slot that it can switch it to. I know that's true.

MS. MULKEY: Paula, do you have a sense, any kind of quantitative or qualitative sense about what kind of either new actives or new uses are sort of interest to manufacturers but not submitted?

MS. PAUL: What I know is our company does have some, you know, we look in terms of our progression. We do have some actions that are not submitted, or it impacts our research planning in the sense that when we have a list of things to do we'll say, well, even if this was completed, it wouldn't be -- it wouldn't qualify for a priority slot or, you know, it isn't reduced risk. It isn't -- so it tends to fall to the bottom of our internal priorities in terms of getting work done.

So it certainly does have an impact on our decision making in terms of what work we complete, and at least in my conversations with other companies that is also the case. I mean, in one sense it probably does what the agency is looking for, you know, it allows you to -- it encourages you to emphasize the reduced risk. On the other hand, I think you have to ask the question then what is it de-emphasizing, and, you know, even products that don't qualify for reduced risk status, because that is a fairly strict criteria, certainly have some positive benefits perhaps over existing products whether it be performance or compatibility with IPM or sustainable agriculture.

So, it's getting back to the philosophy that if you want to make changes in agriculture and take products off the market, if that's something that's in the future, it's important to keep the new products' development going as strongly as possible so that you have replacements and options available.

MS. MULKEY: Steve?

MR. BALLING: Thank you, Marcia. I just wanted to follow up a little bit on Shelley's concerns about IR-4's priority setting. Gosh, about a little over a year ago after IR-4 had gone through a USDA review and through the strategic planning process, one of the things that we, as stakeholders, emphasized is that IR-4 should shift priorities to the reduced risk compounds, and into the new chemistries, and really begin to move back closer to the earlier registration of a lot of these new compounds and move away from organophosphates.

And it's my understanding that both in terms of organophosphates and carbamates, the only uses are the only petitions that are going through are those in which the work had already been done, and the information is valuable to EPA in terms of reassessment of risk.

So I strongly compliment Dan and IR-4 on the fact that they really have begun to shift significant resources, if not 100 percent of the resources to reduced risk compounds.

The other comment I wanted to make is this relationship between IR-4 and the EPA. I've been involved for 13 years, Dan, and I have never seen a better relationship between the two groups, and in fact, because of IR-4's role and EPA's responsiveness, we were able to obtain this usage of biphenthrin on several of our crops, and I figure just a rough calculation that we'll be able to replace usage of organophosphates on over 40,000 acres over the next two years. That's a pretty significant reduction in use of organophosphates, and it's because of that cooperation between those two groups.

MS. MULKEY: I might add that I believe that our volume, this is a quality volume issue. I believe that our volume success in IR-4 is directly related to the kind of compounds that the IR-4 petitions are associated with for the very simple reason that the science is easier on these reduced risk compounds, and that is the sort of limiting factor in terms of level of effort that's necessary for us to work on one of these.

So from where I sit, I believe that there is a direct -- if you wanted to pick one source of the success we're enjoying, I believe it is the choice that IR-4 made apparently with the help of a lot of good advice to focus on these kinds of compounds. They are easier for another reason. They are compounds that we're actively working on, because they are our priorities for the major uses, too, and so you piggyback the expertise, and, you know, you have sort of a current reviewer with current knowledge of the tricky issues associated with that compound. So Jim, do you agree?

MR. JONES: We have literally had conversations with IR-4 that went like this. They've done the work four or five years ago on a particular compound, it's a B-2 carcinogen, developmental product, and we'd say, well, you know, we could work on it. It would take a huge amount of resources, or we could do these 25 reduced risk uses. I mean, they have been smart enough to say, we'll take the 25, and we'll put that thing off, and it just won't get done. And that kind of conversation leads to what you're talking about, Marcia, is that you can do more and it's better stuff, frankly for everyone.

MR. KUNKEL: One other example would be the tebufenozide we did this year. We had the data. We did it in 1996, and the agency was reviewing a chemical company's tebufenozide project, and they asked IR-4 for the data, and we reviewed them all together and got the registration.

MR. AMADOR: Marcia, I don't mean to butt in, but it might be an appropriate time for Dan to kind of briefly review how the projects, the IR-4 chooses to work on, because this is not a request of the manufacturer, it's not a request of EPA. It's a request of the producers, who are very vulnerable, because they don't have enough products cleared. So you may want to review briefly.

MS. MULKEY: We have time, I think to have that interruption and still have everybody --

MR. AMADOR: And also can you explain to people what IR-4 means, because some people don't seem to quite know what the IR-4 initials, the acronym means.

MR. KUNKEL: Okay. I'll try to cover all those topics as quickly as possible. First of all, what does IR-4 mean. It was one of several interregional research projects that were started in the early 1960's, and I believe we're the only ongoing interregional research project that's supported by the USDA.

Now, how do we set our priorities, how does the process begin? The process begins with the pesticide clearance request form that we receive from growers or commodity groups saying we want this particular pesticide on this particular crop. That starts the ball rolling.

We go to the company, and we say, if IR-4 develops the data for this registration to establish a tolerance, will you register this new use. If they say yes, then we take the use to a workshop that we have every year in August, and we have growers there, university scientists, extension agents, they all sit around a table like this, and we bring up each project. And we say, okay, we can only do 150 projects. What 150 projects do you all want us to do. And then they vote on the projects, which ones they want us to do the next year, and then we start moving it into our resources.

We show the Environmental Protection Agency what projects we have, and we go ahead from there. But all of our projects are really selected from the growers, grower groups, extension agents. They decide what kind of research we're going to do.

MS. MULKEY: Thank you. Larry.

MR. ELWORTH: I mostly have questions for Jim, but actually in honesty, I've been real interested in the Antimicrobial Division stuff. I didn't know much about it even though I had some contact with OPP, but I would ask Frank, if we're going to get an update on that antimicrobial underwear. How is it going? Personal interest.

MS. MULKEY: You can count on Larry for our first serious laugh.

MR. ELWORTH: Jim, what percentage of the OPP resources are allocated in FTE's registration?

MR. JONES: The quick math would be 167 -- for synthetic, non-antimicrobials it would be 167 over 850, is that right?

MR. ELWORTH: No, but I mean in terms of the registration program overall.

MS. MULKEY: It's somewhere between 25 and 35 percent.

MR. ELWORTH: Okay. This goal of 13 new actives, that's just based on taking the budget you have available, it's a management decision rather than you think -- this isn't a determination by OPP that all we need is 13?

MR. JONES: No, this comes after a rather elaborate planning process. We're actually in the middle of it right now with our science divisions planning FY2000. It is somewhat contingent that you're going to get a budget to sustain that in October, but we'll assume we're going to assume next year what we have this year, and we spend much of the late spring and early summer planning with the science divisions exactly what they are going to do, and that is culminated in the work plan that will be ultimately published.

MR. ELWORTH: So it's an efficient allocation of resources. It's not any external determination of what we need is 15 or 20?

MR. JONES: That's right.

MR. ELWORTH: When you talk about going from 59 to 56 days to try to meet this goal on Section 18 processing time, what are the hurdles that you're running into that you need to deal with in getting the time down to something that you're comfortable with?

MR. JONES: I'd say that the biggest hurdle is that we will every year get some, you know, a number of section 18's that are very difficult to make a safety finding for, not necessarily because they are risky compounds, but because we have never seen it before. We get some -- we get a handful every year of section 18's for unregistered active ingredients that can be very safe, yet it takes a lot of energy and effort to make a safety finding in that arena, and those are the uses under section 18 that can take a long time to do.

MR. ELWORTH: Is that the complexity or the unfamiliarity with the compound, or is it something that can be dealt with in making clear to applicants what kind of data you're going to need for a safety finding?

MR. JONES: It's both. It's because you haven't basically finished your review of an active ingredient. And so you're trying sort of to move that through as expeditiously as possible. You know, the statute does and our regulations do consider, you know, it is certainly okay to submit an emergency exemption. If you have an emergency for an unregistered pesticide, perhaps we need to be more clear about just how hard they are for us and we do try to discourage them, but, you know, we can't say you can't submit that, because it would take us too long.

MR. ELWORTH: Right. I understand. I want to follow up from a different direction on Ken's discussion about evaluation. There is an enormous amount of discussion because of FQPA about the availability, the need for, the transition to or whatever use of alternatives. The kind of evaluation that I think would be useful is to evaluate once registered how effectively new materials and new uses meet priority needs of growers. I mean, it's one thing to register 12 materials. The question is having registered them, those materials, how effectively are they meeting the needs that led us to think that we needed alternatives or additional options. I'm not sure how you do that exactly, but I think it's real important if the agency is going to spend resources on this, and if the expectation is that once something is registered, then growers have this what the heck is wrong with them, why do they still need this or that chemical. I mean, it's really important to figure that out.

MS. MULKEY: Would you look at things like market share and use percentage crop treated kind of data and try to track it? Would that be a start for the company you're talking about?

MR. ELWORTH: I think it would be a quantitative start for what we're talking about. Part of the reason I ask this is my assumption is on so much of this new chemistry as Jim is saying, if it's unfamiliar to the agency, the use of it is certainly going to be unfamiliar to the growers. It's going to be narrower spectrum. It's going to take more information.

It's going to take new ways of looking at this chemistry and two things. One is, is this meeting the need, do growers really have what they need. But, secondly, what kind of investments do we need to make in making sure that once growers have new technology, after you've done your job, anybody can use these things.

MS. ANDERSON: A lot of the registrations that we do are conditional registrations, where companies actually have to estimate what their market share will be especially over that point, and from my understanding of looking at it, and I'll think of the registrations of Bt corn, people had no idea what the adoption rate of that one was. The estimates from the companies was at five percent of the acreage would be done by the year 2000. It's going to be 25 percent.

So it is something that we try to look at it. In doing it for biopesticides, one of the real problems we have is that they tend to be very small companies who don't have the market force, who can't go out there and really show growers.

So we're trying to work more with USDA in what we can do for some of these projects to actually help them be some of the voice of tweaking the system so that this is how you make the product work better in the actual use situation. So we really need our federal partners at USDA to help us with some of that.

MR. PITTS: Larry, that is an issue and we also had discussions about that -- (inaudible) -- a lot of concern up there -- (inaudible) -- 60's and 70's when there seemed to be a lot of effort to get --

(inaudible) --



MS. MULKEY: Let's give the man a mike.

MR. PITTS: -- something that's not been invested in adequately as far as the Department goes, you know, things that we're going to be looking at is further ways we can work with the private sector and other organizations that aren't governmental to work on those projects, but then also taking a very, I think we need to take a good second look at the pesticide applicator training program and see what kind of role it can play, and I think it can play a very important role, and it's something that needs to be done.

And I think those of you that have followed that program, its funding has been pretty much stagnated about $1.5 million per year. Most of that, if not all of it, comes from EPA. So that's certainly one way to approach that. But it's agreed. One thing we're hearing from growers when we talk about replacement products and technologies is who is going to help us sort through this.

MR. ELWORTH: It might be something that we want to address when we get the PESP stuff, too, Janet, to see, that that's a logical link back from the registration program, at least from your part of the registration program back to the grower community.

MS. ANDERSON: To the whole registration program. We actually look at, and we'll discuss that maybe later this afternoon.

MS. MULKEY: We're doing a pretty good job on time, but we will complete this group, and I think if we do that, we'll take our break close to on time. Carolyn?

MR. BRICKEY: Yeah, just a couple of thoughts. One is with regard to this, the IR-4 program, I'm glad to have you come and give us a report today, because we all hear about you and never meet you or talk to you. You might not consider that a good thing in the future.

I would suggest that maybe you come back to our next meeting and talk to us more about what you're doing with your reregistration activities, because this is a publicly funded program. We are interested in how public health and worker safety and other issues fit in to what you're doing in terms of your reregistration goals, and I don't want to state this morning that I think you're, just rotely reregistering products without thinking about those things, but it would be good to hear from you about what you are doing in that area, and we want to give you a chance to think that through and prepare a little report for us on it.

With regard to Section 18, Jim, I thought that the policy was that you were not going to use Section 18's for products that had never been registered and that maybe there was some giant exception to that in certain cases, but in general that was going to be your policy. Am I wrong about that?

MR. JONES: We very much discourage it, but we do get two or three every year. They are almost always for active ingredients that have been submitted and are in review, but they are not registered yet.

MS. BRICKEY: So how many a year roughly do you get?

MR. JONES: I'd say about three this year. I think this year we've seen about three.


MS. MULKEY: Thank you. Well, there is some increasing interest, which is not a bad thing, but it may threaten our timetable. Have you finished, Caroline? I didn't mean to move away prematurely.

MR. McALLISTER: Thank you, Marcia. My question is just a quick one for Dan. You mentioned you develop risk mitigation strategies for existing registered products. Do you have any examples you could send to us, crop specific examples? As a grower group, I'd be real interested in having an example or a list of strategies.

MR. KUNKEL: For the most part, risk mitigation is we're kind of standing by to see how the risk assessments turn out. So we don't have a whole lot of immediate data. Some of the data we generated for reregistration probably could be used for some risk mitigation, and we could go through those on a case by case basis.

But by and large, we're waiting to see how the reassessments turn out, and if risk mitigation data are required and the companies aren't going to generate it for certain crops, then maybe IR-4 would entertain generating data for risk mitigation.

MS. MULKEY: When Bill gets to the science policy update, the one that's sort of about to be issued is the one on bridging data. It's basically what kind of data set might you need if you wanted to support lowering of a tolerance as a result of lower rates or a change in the pre-harvest interval -- I think those are the kind of data that this colloquy is about, and so that presumably will also be a helpful piece of people's ability to look at supporting reduced tolerances as a means to address risk issues.

UNIDENTIFIED MALE SPEAKER: I've got a few related questions here. On one of Jim's first slides where it showed the OPP resources for registration, the contract dollars show approximately 20 percent cut from 1998 to 1999. I wondered how this had affected the registration activities. Is that all concentrated in one area, is it spread across biopesticides, antimicrobials, and conventional chemicals?

MR. JONES: We did have a cut at the beginning of last year, and it was spread across the three parts of registration as well as other parts of the program, OPP. Ours was more than restored, because we then got more than that back in synthetic pesticides, in the million dollars that came from the deputy administrator.

MR. McALLISTER: What's that picture going to look like next year?

MR. JONES: Too early to tell I'd say.

MS. MULKEY: In the president's budget submitted, I believe it restored us to '98 levels plus a boost in this part among other parts of our program. So I believe the president's submission would put us beyond '98 levels. It was sort of using '98 as a baseline instead of '99, which is why I'm acting so confused here.

So I'm a little unclear about how it relates to '99, but as to '98, it was a restoration of -- because the president's budget in '99 also had basically either steady state or modest growth from '98. So this budget starts from '98 and has some increases in these areas in it.

MR. McALLISTER: So it's not as bleak a picture as we're hearing about six months ago?

MS. MULKEY: Well, the president's budget is not necessarily the budget that the Congress passes.

UNIDENTIFIED MALE SPEAKER: On the list of priorities, I think it's page eight in our handout, you mentioned the USDA EPA vulnerable crop pest combinations, and I see this listed every time, but I never hear anything about it. Is there actually any work being done on those particular priorities?

MR. JONES: Yes, there were a couple on this year's work plan. One of them was actually propazine sorghum, which we were not able to make the FQPA safety finding for, but that was how that got on this year's work plan. And another one we did this year, and I can't recall what it is, it probably would be important for USDA and us to get together again and think about revising that. It was done four years ago?


MR. JONES: Actually Theresa was at EPA when we did it. But USDA actually published. We may want to go back.

MR. McALLISTER: Yeah, I was leading to that, because I've heard criticism of that list because it is so old and given FQPA and change in priorities, it may need another close look at it to see if it's really meeting its purpose, and since it's one of those that comes ahead of most of what I would call the registrant priorities, we're very interested in its effect on other activities.

MR. PITTS: And, Ray, let me just say that we do need to update it, and it had been used as a driver for the Pest Management Alternatives Program, and I think those of you that have followed the RFP's for that program, we -- (inaudible) -- for the most part from that list in the last round and focus more on ongoing discussions with -- (inaudible) -- implementation and what's looking like it's at risk now. And I think the things that you had seen on your list, we create today and in the future it's going to be some of those OP replacement technologies, in particular, which are even above our priority list anyway.

MR. McALLISTER: You mentioned that you expect to accomplish roughly two-thirds of the identified eligible active ingredients this year, 13 out of what, 20 on the list?

MR. JONES: Well, complete and register are different. We did contemplate Gentamicin, however, it was withdrawn. How you capture our completion on l--

(End of tape.)

UNIDENTIFIED MALE SPEAKER: Work is proceeding on those five?

MR. JONES: That's right.

UNIDENTIFIED MALE SPEAKER: So they are sort of first on the list for next year, or --

MR. JONES: Well, they will -- some of the problems that we find is that problems arise in the assessment that can take longer than a few weeks or months to fix.

MR. McALLISTER: But it's not a matter of them going back into the hopper and being sort of --

MR. JONES: That's right. They will not go back in the hopper. They will have top priority going to the point 2000, but there could be a few of them that take more than four to eight months to fix from the registrant side.

MR. McALLISTER: Okay. Just another quick comment. That backlog report you mentioned might be just as easy to post that on the internet.

MR. JONES: That's a good idea.

MR. McALLISTER: And ACPA has done a rather informal survey of planned submissions over the next couple of years which might shed some light on this backlog within industry. We'll take a look at that and see if there is some help there.

MS. MULKEY: I think having taken the lesson of the first commentor, it would be nice if, in addition to numbers, any information that would help us all get a sense on what we're looking at in terms of, you know, either as among insecticides, herbicides, just anything that would add value to the qualitative side. I'm thinking about that kind of thing.

We have now hit our time for the break. In fact, we've slightly overshot it. After Jackie, the folks with their cards up have engaged on this topic, I think we probably should try to close this topic before the break. So we'll give Jackie all the time she needs. She's been patient --

MS. HAMILTON: Jacqueline.

MS. MULKEY: Jacqueline. I'm very sorry. I will try to remember that. But don't hesitate to remind me if I miss it again. I will give Jacqueline her opportunity, and I will ask that the rest of you to try to limit so we sort of stay on schedule. Okay. Jacqueline.

MS. HAMILTON: I'll keep it quick. First of all, I want to congratulate you on your progress in getting reduced risk alternatives registered and moved through the process. Clearly that's a high priority, and I think that's something we're encouraged to hear about. Having said that, it doesn't do a whole lot to have them registered and not have growers know about them.

So I really do encourage you to think about ways that USDA especially can be helping to get the word out. You've got the networks and the contacts with growers, EPA had done their job on registering them, can't do a whole lot more it seems to me than partner with USDA effectively to try and get the word out.

I do have some concern though. I'm hearing that you're increasing emphasis on multi-year section 18's, and I wanted to know why I'm a little unclear, forgive me, with a lot of the history of the Section 18 program. I do know some. I know that one of the things that we're particularly concerned about is the fact that we get these sort of de facto registrations, because Section 18's are continued year after year after year. They are supposed to be emergency exemptions, and while I can understand that one may be able to predict that an emergency that exists this year may again exist next year, I'm concerned actually to hear that multi-year section 18's are a focus and perhaps increasing.

MR. JONES: We would have to do some numbers on the number of multi-year exemptions. I don't have the sense that they are increasing. Multi-year exemptions for emergency exemptions have been with us for some time, probably for the life of the program. But we could give some trend information to you on what is the average number of years a specific state gets an emergency exemption for the same chemical on the same crop.

MS. HAMILTON: That may be really helpful.

MR. KUNKEL: I may be able to add something to that, too, and I think some of the multi-year ones that at least that I was talking about were some of them that we did not have scheduled, EPA did not have scheduled for '99 review, or they did not have it scheduled for fiscal year 2000 review.

So we knew that the agency would review it eventually, but since we weren't going to -- they weren't going to review it for Section III registration in fiscal year '99 or fiscal year 2000, and they have provided a multi-year section 18.

MR. JONES: We're actually going to spend a fair amount of time on the next session on emergency exemptions. I think we'll get to some more of your issues.

MS. MULKEY: Thank you. Is it William or Bill?

MR. McCORMICK: This is for Frank, a comment and a question. First off, with the establishment of FQPA, one of the really great parts of it, as far as Clorox is concerned, was the establishment of the Antimicrobials Division. It's really done a lot to make an ignored part of the responsibilities of the registration division give it the attention that it has needed, and Frank has done a lot to keep that process open and invigorate his staff, and you should be commended on that.

I think as AD gets older and emerges out of its infancy, Ken's comment is one that I think we need to pay particular attention to. You're meeting all these deadlines, and that's fantastic for us. I am concerned a bit about the quality issue, and I'm wondering if you have any plan in place to assess quality.

MR. SANDERS: Quality is a great concern of the Antimicrobials Division as well as I know of industry and other parts of federal government, other federal agencies. We do have plans to deal with that. We believe peer reviews is another way to go. It's a way in which, I believe, the other part of the program is engaged in.

Antimicrobials Division is in the process of establishing peer reviews, and we do continuously work with HED and using their peer review committees whenever appropriate and possible. We do believe that we need new methods, need new protocols, and all of these kinds of things are in the works and are in the development of stages.

So we recognize that while quickness is important, quality is also equally important, and we do intend to assure ourselves as well as assuring the public that we have in place mechanisms to assure quality of the data reviews that take place. And so peer reviews is one area.

Methods is another area. We're contracting out with a number of universities as well to help us in development of universal methods, and we believe this is the right way to go. We also have a testing program, as you may be aware of, with the new laboratory that also is going to be helping us, the laboratory established out of Forte Meade is another way, another vehicle that will assure us that we are -- we are registering products that also meet the quality tests.

MS. MULKEY: Well, you're going to have the first and the last work -- that seems fitting for your first session with us.

MR. STICKLE: I wanted to ask Jim a follow-up question. Back in January the PPDC had a really excellent discussion on inerts, and there was some discussion of what was happening on inerts, what the backlog was at that time, what the backlog was on the six inerts that were held up prior to FQPA and what was happening with food use inerts versus polymer exemptions and how they were being processed. I wonder if Jim could just take a moment to bring us up to date on where we are in that process.

MR. JONES: We have not made as much progress as I had hoped six months ago. I think at this point we had hoped we would have made the FQPA safety finding for about ten food use inerts, and we've only done it for three. We do want to pick up the pace the rest of the fiscal year and get ourselves into the range that we were last year, 10 to 14.

We have spent a lot of time with scientists in the organization attempting to develop some methodology that will allow us to make the aggregate risk finding. The FQPA safety finding, which includes aggregate and cumulative risks can be very complicated for an inert ingredient that has multiple non-pesticidal uses. That's what we've been struggling with, and although the compound itself may be a very safe compound, you still need to make the safety finding. So we've been struggling with coming up with a methodology that would allow us to do that, and we spent a lot of time this year developing it.

We've actually got a draft methodology right now that I think after a couple of weeks we'll be sharing more broadly with interested stakeholders. I think once that methodology becomes operational, we'll start to see our ability to make safety finding increased in the very near future.

MS. MULKEY: Well, thank you. We are running about ten minutes behind. So please stick to the ten-minute break we allocated.

MS. MULKEY: Which is a set of sort of outstanding rules and rule related activities, which is also in part response to your requests and partly sort of the old business calendar of this group among others. The Section 18 Rule certainly falls into that category.

There was a period of time when this group was very actively focused on a set of issues relating to Section 18's. The tolerance fee rule is in the public comment process, is that right? Have I got that right? And so it's a good fruitful opportunity to be sure people are focused on the -- actually the Section 18 rule is also, the pendency on important rule making.

And finally fee for service is a discussion essentially primarily between the synthetic chemical registering community and EPA, but one where there is certainly going to be and needs to be opportunity for at least awareness in the larger community.

So those are our three topics for this next session, to which we have sacrificed almost 20 minutes of our agenda. So we need to focus, and so we'll ask Jim and Anne to kick it off with 18's.

MS. MULKEY: Okay. The tough question is whether we go through all three and then have a dialogue, and I'm inclined to that to insure that we give all three of them sort of equal time, but if there is strong resistance to that, speak now. Okay. Let's do that. Let's do all three presentations. Thank you.

MS. LINDSAY: I am going to try to give you just a very brief summary of the Section 18 rule that we proposed on the 3rd of June. This is a rule that governs only the criteria and the procedures for setting tolerances in conjunction with Section 18's. And that setting tolerances with 18's was one of the significant changes that FQPA brought us, and I think FDA, in fact, was fairly instrumental in pointing out the need for that kind of legislative change, and for that we're appreciative. For all of the work that's flowed, I think we're still appreciative as well.

We proposed this rule on the 3rd of June, and the comment period actually officially closes the 2nd of August. So just a couple of weeks from now. In setting this requirement in place, FQPA basically holds these tolerances to the same safety standard that permanent tolerances or tolerances for permanent registrations are held to. So you have to make the same reasonable certainty of no harm finding. You have to consider the same factors, the special sensitivities of children, aggregate exposure, cumulative risk and so forth. There must also be a practical method. So all of those things that would apply to a regular tolerance apply to an 18.

They are different in two ways. One, the statute tells us that they should have an expiration date, although it doesn't specify a specific time period for the expiration date.

And secondly, in, I think, recognition of the fact that if you're going to have an emergency provision, you have to be able to move quick. These Section 18 tolerances do not have to go through a notice and comment procedure the way a tolerance for a regular section three registration would have to go through.

The proposal that we've got out on the streets basically suggests that the agency after considering a number of different approaches believes that the best way to actually make decisions on Section 18 tolerances is a case by case approach, and that, in fact, is basically what we've been doing since August of '96.

Reasons for that are probably pretty obvious to you, but we think that it promotes the sort of timely decision making. Generally dietary exposure is less for the Section 18's because they may be of limited acreage, limited time duration. In most cases we have substantial hazard and exposure data on the chemical in question. The issue is just the particular crop. So except for these brand new never yet registered active ingredients that we talked about before the break, we know a lot about the chemical already when we're looking at a particular Section 18 request. And this case by case approach to us would both limit resource burdens for agencies, for state lead agencies, for grower groups, and registrants in actually putting together a request and evaluating it, and allow us all to put our resources into things like tolerances for regular registrations, reregistration, and elsewhere.

Other approaches we did think about, and they are enumerated in the preamble to the rule, should we require the full data set comparable to what we do for registration on a permanent tolerance. Obviously if you do that, that pretty much actually precludes issuing a lot of Section 18's or virtually all of them. Some kind of minimum data set.

And then finally we also, and here PPDC was helpful in this regard, have invited comment on an incremental approach. I won't go into the details of the incremental approach, but that's also in the preamble, and we're inviting comment on it.

Other things in the rule -- we're generally talking about an expiration date for these tolerances of 24 months, although we're not specifying that it must be 24 months, because there may be cases where you want a different expiration date. We're anticipating what I call automatic revocation, like in the tolerance it sets a date at which point it expires. Again, that's a resource saving approach to how you might do things.

A couple of things about scope of these Section 18 tolerances that are discussed in the rule -- we do point out that a Section 18 tolerance for the period that it is in effect will apply not only to domestically produced commodities that were treated under a Section 18 exemption, but will also apply to import commodities for the duration of the tolerance. That's actually been an issue of some interest to a number of our trading partners, not just our NAFTA trading partners, but from elsewhere, and so we specifically point this out in the preamble.

I think that's all I really need to say about the rule proper at this point. Depending on the nature and volume of comments that we get on the rule, I think it is what I call a modest size. We're probably talking about a final rule in the spring next year, spring of 2000. If we have tons of comments, I think the time frame would be longer.

There are some other things in the preamble of the Rule. In fact, eight specific areas of possible change for the future that don't relate to actually setting tolerances for Section 18's. They relate to the operation of the program under FIFRA. We did invite comment on them. I point out that if anyone does comment on these eight recommendations for change, which came primarily from NASDA, the National Association of State Departments of Agriculture and AAPCO, we've got a separate docket. We're trying to keep the comments on the rule proper and the comments on these changes very cleanly separate just for rule making purposes. And Jim is actually now going to talk about those eight other areas of change and what work has gone on there.

MR. JONES: Thanks, Anne. There in your packet should be a two or three pager, the top reads Section 18 Reinvention issues. Each of these eight were identified as areas of potential reinvention surrounding the Section 18 program identified in the notice that Anne just discussed.

In addition, five of these eight were topics at a workshop that OPP held just after the passage of FQPA. The timing was not planned. And so there has actually been a fair amount of dialogue with stakeholders on five of these, and I'll highlight those. The first area is economic loss definition. We have a very specific definition for economic loss that we use in determining if something is an emergency.

It basically involves that the economic loss predicted in the year because of the emergency would get profits outside the five-year historical range that the grower has experienced. It's rather specific in that respect. What we heard at the workshop that we held several years back was that the agency should allow greater flexibility in determining whether or not the economic losses that have been suffered -- that will be suffered are significant.

The basic issues here, there are some crops that have tremendous volatility in their profits, and for such crops, it can be very hard to get outside the five-year range. Other crops, such as field corn where there is not much volatility in profits being outside that range is not easier to achieve. That's the motivation behind the user community basically saying we should apply greater flexibility in how we document economic losses.

The second is how the agency determines if there is an emergency. The state basically makes to us -- they follow our guidance, and they make to us a case as to why they think there is an emergency. Feedback at the workshop that we held three years ago, that the Agency should basically allow the states to certify that there is an emergency as they are closer to the situation and have a better feel for what is going on, and that the agency's evaluation is an unnecessary duplication of that. That is what the stakeholders at the stakeholder workshop said.

The third area, which was not discussed at the stakeholder workshop but was brought up by NASDA to the agency, when we were going through the development of the Section 18 Rule, was a recommendation that the agency should implement an audit, a performance audit program of the Section 18 program, and that's something we're giving very serious consideration to right now.

I think that there are a large number of areas in that program where I think it would be valuable for us to have some external group come in and look at both the work that's being done by the states as well as the work that we're doing at EPA. So although we have not determined yet, we are going to go forward. It's getting very serious consideration inside the agency right now.

The fourth area, and this sort of begins where we get into a little more of where I think there will be a fair amount of dialogue over time, is a recommendation that the agency consider multi-year exemptions. Currently our regulations limit us for a specific exemption to one year. The agency can grant Section 18 for up to one year for the use of a pesticide on a crop. An exception is quarantine exemptions are allowable for up to three years.

But the standard basic, your every day Section 18 specific requests is limited by regulations to one year. At the stakeholder meeting there was a recommendation that under certain circumstances, basically the state recertifies that they have an emergency and that the authorization be allowable up to three years was the recommendation that we got.

The fifth area is a -- it was recommended that we should actively support and coordinate regional Section 18 requests. We have actually adopted that, and over the last five years probably starting with the potato late blight issue that was faced by much of the potato growing region of the United States, we have begun working with states and actually have several experiences under our belt where states get together, and we get one application that sort of has the documentation necessary to support the Section 18. The other states in the region basically then just send, you know, one page saying we also would like to be part of this regional request. We've seen that and have participated with states in a handful of those over the last couple of years.

The sixth recommendation that was made, but again, this is a NASDA recommendation was that the agency should establish reasonable monitoring criteria for approaches to wildlife and endangered species. We had with carbofuran or furadan some Section 18's issued in '92 or there abouts or '93 imposed on the state monitoring requirements. The states found it incredibly burdensome, and to monitor for an acutely toxic pesticide that may have effects or acute toxicity on birds, basically lethality, to do that in a way that gives you scientific confidence in the results requires a very elaborate monitoring process and program. And basically the states were unable to handle it, and so we have in that specific case, we have pulled back from that monitoring requirement on the state and are considering the applicability of it for the manufacturer, who would have more resources and more responsibility, frankly, for doing that kind of monitoring. So in the example of carbofuran, we have pulled back on the monitoring requirement that was being imposed directly on the states who had the Section 18.

Resistance management, this is somewhat of a tricky one. For Section 18's we have basically the current approach is that if resistance is developing, but the registered alternatives are still effective, we have not allowed that to be a criteria for issuing a Section 18. We have required that there be resistance that's already documented, and a recommendation that came back from the stakeholder workshop that we had was that we consider the resistance developments, the process of the developments to be an allowable criteria for the granting of a section 18.

The final issue is reduced risk. This is a very interesting one for us. Currently if you have a registered product that controls a pest on a crop and it works for pest control, and there is however a reduced risk product that is not registered on that crop, we do not allow and we do not believe our regulations currently allow the consideration of the reduced risk compound for that situation as you have a registered alternative.

Stakeholders from the public interest community, the agricultural producer, states, and industry were represented. The public interest representation was pretty narrow. There were a few people there, and they I don't think necessarily agreed with some of the earlier recommendations that came out of the stakeholder group. This was an area where they were right there with everybody else in the group that EPA should consider a reduced risk compound for an emergency exemption even in situations where there is a registered alternative, and it is efficacious. Those basically are the eight areas that are mentioned in the notice.

We have made commitments coming out of the stakeholder workshop that the five that I have mentioned, we would be coming out hopefully in the very near future with some kind of a proposal as to how we will address them. I think it's likely that the additional three will also be addressed in whatever proposal comes out and each of these issues is an active consideration right now within OPP. I think we're going to be looking today for a little input from this group.

MS. MULKEY: Okay. We are going to continue to complete this segment, but I'm sure you've all noticed that Jim Aidala has joined us. As we said this morning, he would be here at the earliest possible time in his day. And so he's here now. And so we'll give him an opportunity to greet you and get a little sense of what's on his mind.

MR. AIDALA: Let me not interrupt the flow here. Sorry I was late. We had some meetings on the Hill and also some meetings with the administrator and deputy administrator. So, again, I apologize. Up until 12 hours ago, I had fully intended to be here at the crack of dawn meeting wise, and again, apologies for that. But why don't I just we can either during a lunch break if there is something we're saying, we'll just do it after that instead of interrupting the flow now.

UNIDENTIFIED FEMALE SPEAKER: Can I ask a clarifying question about the presentation just made?

MR. AIDALA: Don't ask me.

UNIDENTIFIED FEMALE SPEAKER: Do I have this right, I haven't had a chance to read the Section 18 Rule yet, the proposed rule, and do I understand correctly that these eight items are included in that Federal Register Notice, is that what you were saying?

MS. LINDSAY: These eight items that Jim just discussed are almost verbatim in the preamble of the Rule. It's a little bit unusual rule making, because we're inviting comments on the proposed rule itself. The proposed rule doesn't treat with any of those issues, but because we also have these issues in the body of the preamble, we have also said those who would like to give us comments on these other issues may do so, and we actually have established a separate docket for those comments.

Our general counsel's office actually looked at us a bit cross eyed. I think not being an attorney, I thought it was totally sensible, but I understand that it's a little bit irregular, and since our attorneys are paid to keep us on the straight and narrow, we came up with the two docket approach.


MS. MULKEY: All right. You will all feel a little bit of disconnectedness, because these latter two items, which arguably have some relationship to each other are pretty disconnected from the Section 18 topic, but in the interest of, as I said, assuring that all three topics get your opportunity to have us focus, we'll follow with the next, which is the other rule making. The Office of Pesticide Programs doesn't engage in a whole lot of rule making. So to have two active at the same time is a pretty high level of rule making activity for us, and the other one is the tolerance fee rule, and Carol Peterson, who is in our Field and External Affairs Division, is going to provide it.

MS. PETERSON: I'd just like to give a brief update of the tolerance fee proposal. It should be in your package or at least part of your package. If you need anything to read on the flight back, feel free to pull out the tolerance fee proposal, and it will put you right to sleep.

But as mentioned, it has been out. It has been out for a while now. It was published June 9th. We are about halfway through the comment period. I'm a little bit scared, because I haven't received any comments yet, and I have a feeling I'm going to get deluged with comments on September 6th, and these comments aren't going to be one-pagers. I've been assured of that.

I did meet with a couple of industry groups yesterday at a very informative work group, and I discovered that there are a lot of questions out there. There are a lot of issues out there that do need to be resolved. So I think this proposal is by no means black and white, and it's by no means anything that's going to be easy in the next year or so.

But to give you a brief overview of what it's all about, tolerance fees are not anything new to the program. We put tolerance fees in place in 1972, and we last updated them in 1986. But as everybody realizes a lot has happened since 1986, and these tolerance fees that are on the books are obsolete. So we've decided to revise them.

Needless to say, FQPA had a hand in this. Basically because it changed the tolerance fee statute just a little bit, but enough to make a big difference. There is a lot more things that require tolerance fees now. Before we just collected tolerance fees on raw agricultural commodities under 408, but now because 409 does not exist any more and because 409 got incorporated into 408, this pulls in all tolerances on processed food and tolerances on feed. So those will now be subject to tolerance fees.

In addition, inert chemicals are now part of the official definition of a pesticide. So now tolerances on inerts are subject to tolerance fees. I try to envision this as a great big umbrella, and the umbrella is getting bigger and bigger and more things are now underneath the umbrella that are now subject to tolerance fees.

By far the biggest change is that now reassessed tolerances are now under the umbrella. So the 9,700-and-whatever tolerances that are on the books that have to be reassessed in the next few years are now subject to fees, and we now have to collect the moneys to fully cover reassessing those tolerances.

So to say the tolerance fees on the books are just getting revamped is kind of an understatement. They are getting a complete overhaul, and what we essentially are proposing is two separate fee systems. One for new tolerances that come in with a petition, and one for the reassessment of existing tolerances.

We revised the categories, what types of tolerances, and we were basing our fees on the actual resources that the agency has estimated that it uses to process this type of tolerance. For example, a new active ingredient coming in the door that's used on a food use certainly takes a lot more time and effort than a tolerance modification or a label change. So we have set our proposed tolerance accordingly.

In addition, we put together sort of an incremental approach to tolerance fees, whereas if you've got a new active food use ingredient coming in the door on several different crops, whether you have to set one tolerance or whether you have to set ten tolerances, isn't a whole lot different. So we set the maximum fee to process the very first tolerance, because to set just one tolerance requires tremendous amount of work where we have to review all the tox data, all the residue chem data, virtually the whole package just to set one tolerance, and any other additional tolerance is just a review of one or two extra studies.

So we're setting our fees, pretty much a large fee, on the first tolerance and a very small fee on all the incremental tolerances. Also included are some waivers. We're proposing to grant routine waivers on several categories including minor uses, biopesticides, list 4A inerts. There is a list of about seven categories that we've proposed routine waivers. So that's basically it. It does in a way work in concert some ways and not in concert in some ways with the fee for service, and so we have to figure out some issues there, but we welcome your comments preferably before September 6th, and I'll answer any questions you might have.

MR. JONES: In segue for fee for service, back in 1995 and '96 the agency was in discussions with the manufacturers about a fee for service proposal, legislative proposal that basically just did not come together. FQPA I think sort of got fast tracked, and fee for service wasn't fast enough to catch that train.

Last year we began again in earnest discussing with the manufacturers potential fee for service, and the distinction between fee for service, as I'm discussing here, and the tolerance fee rule that Carol just talked about, is that the tolerance fee rules do apply to the tolerances and reassessed tolerance and inerts that have tolerance associated with them. That money that is collected and generally goes directly into the treasury, in that it actually comes to us, and then we have our budget offset by that amount of money. So the agency ultimately doesn't see an increase in its resources. That, at least, has been our experience with tolerance fees.

So after the tolerance fee rule goes into effect, it is unlikely that there will be more resources available for EPA to do establishment of tolerances or tolerance reassessments. The fee for service discussion that I'm going to talk briefly about is an effort to actually supplement the agency's resource base for the registration, and it is being so far limited to synthetic non-antimicrobial pesticides. Those are the compounds that are in the registration division. This would require not a regulation, but a change in the law and the money would be paid by the manufacturer, to EPA. The agency would be able to keep this money. It would, however, have to be clearly dedicated exclusively to those things for which the legislation allows it to be, which is registration of synthetic non-antimicrobial pesticides.

There have been many discussions with the manufacturers. We have recently begun to also reach out to some other interested parties here. I don't think we've totally captured the universe, but we're on a track to do that. We have met with IR-4, which is very interested in this. We have met with states, which have an interest in this and some other groups that have an interest. I think they are probably coming out of this meeting, maybe some other groups that want to get together with us as well.

What the fee for service proposal as it stands right now and it is this dialogue with the manufacturers is not over yet. I don't think we quite have a consensus yet, but where we are right now is the kinds of activities that would be covered by fee for service include food use, conventional, new active ingredients, food use conventional new uses, import tolerances, experimental use permit. They would have mandatory fees. That is, we would not work on those categories unless they came in with a fee.

There is one category that currently in the discussions are being considered for voluntary fees. That is the manufacturer could choose to pay it, or they could choose not to. If they paid it, they would get the corresponding statutory time frames that would go for it. If they didn't pay it, they would go into the group of activities that were being done based on appropriated resources and that's the current sort of slower review time, and that is non-food use, new active ingredients involving turf and termiticide uses.

And then there is a large list of actions that are not covered by the fees. They would not be subject to fees. They would be relying on our current -- appropriated base for us to work on. They include antimicrobials; biological plant pesticides; in the synthetic arena, registration amendments, fast track actions, non-fast track actions, inerts would not be subject; non-food use active ingredients with the one exception being the turf or termiticide uses and non-food new uses. Those actions would rely on the agency's appropriated base, whatever it would be at that time.

What are the benefits of the fee rule, of the fee for service is that the manufacturers commit to paying this money, what do they get for it, the statute would then include goals for the agency to meet for them, and we have worked to figure out how big the fee would need to be so we could meet these goals. And basically we go from doing a new active ingredient in about five years, three to five years to the goal would be 22 months.

New uses -- 18 months would be the goal. So basically the increased resources coming to the agency would result in faster decision times. And they are decision times. They are not registration times, although we would expect that many of these would be registered in that time frame. Our goals are to make decisions in those time frames.

Those are pretty much the key features. Another feature that we've picked up from our work with the FDA, which we spent some time with FDA, which has a fee for service program right now for drugs, so that we do not at the agency find ourselves so addicted to the fees that we'll do anything to keep them, which can happen. You're getting all this money. You have all these people. You know, you've hired 120 people, and it's going to sunset in five years, and you'll do anything to make it not sunset. So you'll accept anything to make it not sunset. We have created a system whereby if for whatever reason it is determined that the fees are going to go away, there would be an easing off of the fees over a couple of year time frame, and similarly we have sort of a ramping up. So that we're not sort of -- that's from our FQPA experience that you need a little time to sort of ramp up on these things. We're also building in a provision that allows us to ramp down in the event that congress, or we, or whoever thinks that these fees need to come to an end.

The discussion continues with the industry. I think that there are probably some issues with respect to how do we bring in other stakeholders. I think we recognize that these kinds of proposals don't really go anywhere on the Hill if there is a significant constituency that stands up and says this just is not right. So we are working to try to develop a consensus before it goes further, and that dialogue I think will continue for some time.

MS. MULKEY: That concludes the presentations on these three topics. We can call this, I suppose, the law change topics either by regulation or statute. They have that in common, and I think we will again try just some form of wrapping the room with a realization that there may be some zigging and zagging among these topics that results. But with the hope that when it's all concluded, we'll have some sense of the group. Bob.

MR. ROSENBERG: Jim, this is just a question. I'm just trying to -- I don't even know if it's a good thing or a bad thing, but I'm just trying to think through what the internal logic would have been to suggest that the fees for termiticides and turf uses be voluntary?

MR. JONES: We thought that actually the non-food use active ingredients would logically be voluntary, and in general the industry that's involved in those doesn't want them to be.

UNIDENTIFIED FEMALE SPEAKER: Doesn't want them to be voluntary?

MR. JONES: They want them excluded altogether -- the non-food use. They would just be dealt with in the appropriated base process. We think that there are some public interest reasons on the termiticide and turf uses for them to be paying fees in that time to registration decision is reduced, and there are, I think, a lot of issues around currently registered products that we very much want to see those two areas, the development of and registration of newer products. So we have tried to keep them in for the reason that we'd like to see them move -- the alternatives move to market quickly.

(End of tape.)

MS. MULKEY: That's very constructive, I think.

UNIDENTIFIED MALE SPEAKER: Is there an easy way today to compare the level of effort on Section 18's pre-FQPA, and how is it increased in three years since FQPA?

MR. JONES: We have a way to do that, and we do do it internally, and I presented it at the PPDC meeting the last time. Let's see if I can recall.

There was a rather dramatic increase in the review effort as captured in our time accounting system. I think it was something around doubling or tripling, and one of the things we've been doing is watching that over time, and it has fallen pretty dramatically. I think it's now between 30 and 50 percent more resource intensive than pre-FQPA, but it is not at the first year after FQPA where it was double or triple what the pre-FQPA was. So in short, we can do it. We have been doing it. The resource expenditure on that is higher than it was before FQPA, but it is dramatically less than it was the first year after FQPA where Section 18's were very costly for us.

UNIDENTIFIED MALE SPEAKER: I'm concerned at the numbers of actions going through the Section 18 route and if there were -- I'm looking for some broad recommendations from the agency on how to steer the registration activity through the Section Three process rather than Section 18, because that is taking away resources from the full registration actions.

MR. JONES: I think that we could use some collective help on that. I think it's going to involve a lot of players plus states. I think the manufacturers have a role. We will not consider a Section 18 unless the manufacturer has told the state that they will support it. I think everybody in the community has a role in that. I think EPA has got a role in it in terms of registering things more timely, and I'm not sure how much of that we can sort of sort through in the next 15 minutes, but I think it's a very good point.


MR. JONES: Performance audit might help us.

MS. MULKEY: Thank you. Bob.

MR. LAKE: Thank you. My question relates to Section 18's, and my purpose for asking it really is to surface for this group what I refer to or think of as the pipeline issue relative to the termination date of the Section 18 tolerances. And just by way of introducing it, it does occur to me that one of the things that can happen is that after this two-year termination date that there would be domestically produced food in commerce that was put in commerce when the tolerance was still in effect, but continues in commerce after the tolerance disappears.

It also seems to me that there could well be foods produced elsewhere in the world either on the high seas or on the port of entry or perhaps already in domestic commerce as well, and I would just like to ask EPA for their thoughts on how this is going to work. Thank you.

MS. LINDSAY: I think we would have looked to FDA to help us figure out practical solutions to that since you are our enforcer here. If I've got it right, and, Bob, I know if I've got it wrong, you'll correct me or Jim will. For domestically produced things that were legally treated during the period of the actual Section 18, when tolerance expires, and it could be two years down the road from the actual period of treatment, residues in those commodities from a legal point of view are still legal as long as they are within the level of that expired tolerance, although it may present practical enforcement problems for either FDA or for individual states, because I think I've heard from some states say that they have complications with their state laws and regulations. California probably being a case in point, but at least from the point of view from the FFDCA, those are still legal commodities. I think the situation is not the same for the imported commodities as I understand it, and I think it presents a problem. I guess I hoped during the comment period those who were interested in these kinds of pipeline issues would not only raise the question but provide us some food for thought to come up with some good solutions to it.

MR. LAKE: Let me, just as a quick follow-up note, that I think one of the things that could complicate that issue is the possibility that either domestic or foreign producers might actually fudge a little bit, continue to use a pesticide hoping to take advantage of the pipeline, and so I just raise that as something to think about.

MS. LINDSAY: Again, on the domestic side, that would be another issue that perhaps both individual states and AAPCO or NASDA would like to address in commenting on the Rule, because they have some hand in the question of temptations to fudge.

MS. LINDSAY: Yeah, I guess the other thing I will just mention is from the international work I do, there is an increasing interest in the whole Section 18 program internationally from a number of different perspectives both within NAFTA and abroad. So it's come as a surprise to some people, but the Section 18 program I think has truly moved from sort of a purely domestic tool to a very much international issue, I guess is how I'll put it. A number of countries have said to us that while their growers would hope for a Section 18 program of their own, as regulators, they are happy to have the U.S. have a Section 18 program and not to have one of their own. So you get different perspectives from the international quarter.

MS. MULKEY: Carolyn.

MS. BRICKEY: Well, I hadn't thought about the international aspects of the Section 18 program, but I can certainly see that becoming an issue.

One observation I would have for you, Jim, in terms of all these different recommendations that you received and the ones that you put in this rule is that it seems to me that some of the folks who made these recommendations don't understand what the purpose of the program started out to be, and maybe if you go back and revisit kind of what the program is supposed to be and work on those parameters, some of these recommendations would not be appropriate, whether they actually were intended to be improvements in the program or not.

And I'll give you a specific example, number eight, reduced risk. That's not what the program is about. If you have registered alternatives, there is no emergency, I believe. So, you know, the Section 18 program continues to be a frustration for me. It seems like every pressure is on it to expand and grow and continue, and there are all these pressures on the enforcement side that I'm not sure that are ones the agency can adequately cope with, like the one that Bob just raised. I think those unintended problems need to be looked at very carefully before you dramatically expand the program once again.

MS. MULKEY: Maybe there is some relationship between fee for service and Section 18 after all, which is the relationship that Ray illustrated.

MS. BRICKEY: That was my next point, that I do think there is a relationship between the two, and I hope that some of the pressure would be relieved on Section 18 program through the Section III program. But, you know, I'm concerned again that people will have more recommendations for ways to expand and have this program grow, and I think it's got to be a concern.

MR. JONES: I appreciate that comment. I think that those of us who work on this program, myself included, have felt that we've been real pointed headed bureaucrats, because we keep saying what you just said about the reduced risk aspect. It does seem sort of contrary to good public policy, but the statute from my perspective seems to not consider that as a logical criterion for an emergency, but the debate I'm sure will continue.

MS. MULKEY: Thank you. Larry.

MR. ELWORTH: Actually, one thing I appreciate about the Section 18 Rule is that it did lay out all of the proposed alternatives in a way that could invite comment. I thought that was very helpful. Not specifically these eight from the workshop, but the way it provided the opportunity for comment on a wide range of alternatives, that was very helpful.

A couple of questions on the 18 rule, though. One is have you thought about the value of some additional -- of an additional workshop to discuss these issues that you could do in a way that still provided you the opportunity to follow APA, but provided an opportunity to hear some further discussion about this?

MS. LINDSAY: At Jim and my level we talked about it more in the context of the eight issues, because it had been three years, and I think less in terms of the procedural rule, probably mostly because I haven't been hearing anything at all, and we're very close to the end of the comment period. If that's important, I think that it's something that the agency could certainly think about.

MR. ELWORTH: I don't know. I was curious. I think a lot of the potential commentors have been somewhat preoccupied as you folks have been in the last month or so.

MS. LINDSAY: As some of us have also been preoccupied.

MR. ELWORTH: The other issue I want to raise is there is a little bit of discussion about the publication of the Federal Register, and it was my recollection, and I could be wrong in this, my recollection was that the need to publish a Federal Register notice on each of the tolerances individually was actually not a small expense to the agency. And they had to be published individually.

Have you looked at ways to at least deal with pretty significant expense just from the Federal Register publication? And I'm not sure that has to be raised in this rule, but I think, you know.

MR. JONES: We've done some streamlining of the notices. They are still rather lengthy and espousing sort of the transparency of letting people understand exactly how we made our safety finding with reducing the cost of the publication in the Federal Register. And that is sort of the trade off on it. We have reduced the length of the notice by eliminating boiler plates, stuff that's just sort of repeated over and over again. It really isn't specific to the compound and the safety finding on that compound. There is probably a little more on that we could do, though.

MR. ELWORTH: Could you combine the publication into a single notice to reduce expenses?

MR. JONES: Well, the problem is that the tolerance isn't in effect until it posts in the Federal Register, and in the world of registration, a day could be a big deal. People don't want to wait for us to group them altogether. They need their tolerance.

MR. ELWORTH: That's a good point. I wanted to ask a larger -- or at least ask a couple of questions on the fee for service, and I missed a little bit of it. Has it been determined that the fee for service moneys would be spent on FTE's rather than consultants?

MR. JONES: We haven't really begun to work through exactly how we would organizationally execute it. That question is very wide open, and people thinking about it, but no even preliminary decisions have been made about that.

MR. ELWORTH: Because that would be relevant to this issue of ramping up in terms of FTE's and then ramping back down if you lost the funding.

MR. AIDALA: Part of the discussion on that is there is a bias to something if there is one in more of the contracting than permanent people, because you also don't know the flow of products over time, and in addition to being for whatever other motivations about worrying about 100-and-whatever number FTE is if what if the work load suddenly goes down, everyone is doing biotechnology things. They are all buying drug companies again or whatever they are doing, and we don't have the work load to feed the system.

Again, if there is an underlying bias, just trying to do as much as possible with contractors, but then you run into the, and this is what Jim is talking about, open questions about inherently governmental functions and other kinds of issues.

MR. ELWORTH: There is a bigger issue here for me, and it goes back to kind of fundamental tradeoffs in FQPA, and that is if, in fact, there is this idea that vice president is saying there is adequate transition for agriculture, how do we make sure that resources and people are allocated to provide the output in terms of registration, new registrations, new uses, whatever, to balance whatever happens either from a voluntary or regulatory side on change in use patterns, change in uses, elimination of uses, and to me it's not just a resource allocation question.

It's a policy question of making sure that the system produces enough to make up for the uses that are lost. And how can we have that policy discussion within the context of allocating resources in terms of the overall budget of the agency, but also in terms of fee for service to make sure that those fees actually make that possible?

MS. MULKEY: The theory behind the fees is that they reflect true cost, and so that if more demand, then there will be more resources there to supply the demand.

MR. ELWORTH: But demand from which side? Demand from the registrants getting products out or demand from the agricultural side.

MS. MULKEY: Then you have to decide whether you think the marketplace, the free market responds to the agriculture demand through the manufacturers. It is, obviously, still driven by manufacturer demand. Jim, you may want to?

MR. AIDALA: Yeah, I think underlining it there is some element of the more new products, you know, more innovation and faster introduction of market innovation, will have some effect. You're asking a more specific one is what if because of a transition plan, we need these three things, and they are kind of stuck back in the queue. There I think the underlying thought process is that the appropriated base will take care of that. Now, it's a separate speculation about, and I think right now we would think or predict that assuming the appropriated base is at least not catastrophically affected, I mean, even at steady state funding which is small nickels and dimes, cuts over time, but nothing catastrophic like minus 30, minus 50 percent that we'll be able to do more of the kinds of things we're talking about. So assume the innovation products, that may or may not have any role in transition, they are covered by fee for service. The appropriated base then is freed up. Part of that currently going to that function appropriated base is freed up to do all those other things, expanded needs of some not necessarily old chemistry, but middle aged chemistry, et cetera, et cetera, whatever the right words ought to be so that then you can have more flexibility to address those kinds of things, the commodity acts because of FQPA implication needs more help with a transition set of products, whatever.

So the theory would be that the increased resources from the fee for service although dedicated to a particular niche of the workload still benefits and affects the other parts, because it frees up -- we spend a lot of money right now on new, active registrations.

MR. ELWORTH: If that's at least an implicit policy of things that are really going to need to be articulated both for the user community, both for the long term for the appropriators, because you know where they are going to go with this. Geez, what do you all need all this money for, why do you need an increase, you got all that fee for service stuff.

MR. AIDALA: And that's one of the issues that we would have an interest in discussing with the authorizers and appropriators, and I suspect other stakeholders will, too.

MS. MULKEY: We have now reached our scheduled lunch break. It's the price we pay for morning slippage. I suggest we attempt to stop at noon regardless, and if we have to force ourselves to carry over, we'll do that. So all those, Jacqueline, now the price of the choice you made. What we'll do after calling on Steve is I will jump over to call on you, but having done that, I'm asking everybody to try to help us on that schedule. Steve.

MR. BALLING: Very quickly, then, Carol, I did, in fact, read the proposal and thank you. It was a lot of -- several naps on the plane here. So I'm not sure I read the whole thing. I want to get some clarification, and maybe it really applies to Jim's issue as well.

Back since IR-4 mentioned minor use issues, you mention in here that minor use is potentially a problem with these tolerance fees, and that there are protections put in place. But then when I go through the table, there are all these strange petitioned actions in the table like tolerance for an other ingredient, whatever that means, and --

MS. LINDSAY: It's the new name for inert ingredients.

MS. MULKEY: The ingredients formally known as inerts.

MR. BALLING: Was that in here? Did I miss that. My concern is that, in fact, minor use petitions are protected because as it is the economic issues are pretty significant for minor uses, and that's why they are called minor uses. We don't get registrations. You add this on top, and the same thing is true for the bioengineered crop issue that if you have significant costs associated. Already no one is really looking at any of the minor uses for bioengineered crops, because it costs too much money. So that's the question generally.

MR. AIDALA: It attempts to take care of some of those problems. There are waivers specifically in it you may have missed at one of your nap times, as well as a general blanket waiver authority that if there is something we missed, if there is a compelling case that even though it's not technically a minor crop because it's 10,000 acres over the cut off numbers, but it is still a compelling economic reason because it's not that the fee would otherwise be a major factor, we have proposed to have authority to then just waive it altogether.

MR. JONES: IR-4 petitions are explicitly waived in both of the fee for service as well as the tolerance fee rule. I think that the question that you have I think you really need to direct to the manufacturers, how are they going to respond to fees as it relates to minor use development. Whether it be fee for service, which they are very big proponents of, or the tolerance fee rule, which I think they are somewhat nervous of.

MR. ELWORTH: But it's also policy issues, not just a registrant issue.

MR. AIDALA: The policy issue is to be very friendly, encouraging and favorable towards minor uses for a number of the reasons we just talked about -- not in the sense of automatic approval in any way, but just rather that don't let this be something else that is an obstacle.

MS. MULKEY: Jacqueline.

MS. HAMILTON: Going back to Section 18 tolerances, I just want to say again I echo Carolyn's admonition to please keep in mind the purpose of the Section 18 program, and we would oppose great expansions of it. We think that emergencies should be real emergencies. They should be time limited. I think that we would probably be pretty unhappy about having a standard two-year approval as opposed to a one year. We want to if for some reason two years really, really makes sense, we want there to be a whole lot of caveats about the conditions under which that would happen I think. And also this issue about application to imports raises some questions presumably the whole reason to have a Section 18 program or part of the reason to have a Section 18 program is so that U.S. growers can deal with pest problems. I'm not so sure of the rationale for applying that to imports.

As far as the issues in the preamble, these other eight, I have some concerns that the cumulative effect of putting all of these in place would be to significantly weaken or lower the barriers for getting these kinds of approvals and given what we've considered the historic abuse of the Section 18 program with sort of de facto registrations over periods of years for particular crops, that raises some pretty grave concerns.

And as for the fee for service, we don't have a big dog in that fight, but I just want to raise the issue that I appreciate Jim's comment about understanding the need for consensus and not wanting to raise anyone's hackles, and given that there are attempts right now to significantly tie the agency's hands and ability to implement FQPA and weaken the protections that we feel are pretty hard fought, if anything beyond fee for service were to go into something like the legal changes that would be required in order to put that in place, I think we'd fight tooth and nail.

MR. AIDALA: Stand in line. I mean, that's part of the comment about consensus is that, and even that there still are some issues to work out. And by the way, consensus includes all stakeholders, not just ones with big or little dogs in the hunt, number one. And number two, we would be -- and that is our major concern at a senior level, if you will, just the whole political dynamic. Although I do think at this point we have worked hard, staff have worked hard, both our staff and the folks that have been talked to in developing the scheme, and as they talk to other stakeholders in trying to address those issues there is a real working assumption -- nothing is subtle, nothing clever, everyone has got to understand it, and agree to it, and hold hands, and jump over a cliff or whatever together.

MS. MULKEY: All right. We'll go back now to Dan.

MR. BOTTS: Thank you, ma'am, and just to kind of alleviate some concerns of people who haven't received comments yet on any of these proposals, they are coming. And specifically I'd like to address the tolerance setting provisions under Section 18 and leave the fee for service and some of the other issues for later conversation in light of the fact I've got a minute and a half.

One of the issues, and it's one that we raised right after the law passed and still continues to be an issue, and I don't see how it's addressed in this particular provision is the fact that there is a crisis provision associated with a specific exemption and other exemptions there which also would require the establishment of a tolerance. There are pipeline provisions included in this proposal that would allow under a specific exemption for uses to be covered under the pipeline provision after the tolerance was established, and the crisis exemption situation in a lot of cases, those uses had been allowed and put into place prior to establishment of that tolerance.

And the way this is currently drafted, there is no protection for those people who have used a product during that 14-day period possibly 28-day period of use. That's a major problem. We're going to have to deal with it somehow in this process.

Another concern that I have, probably dove tails into the fee for service and the tolerance setting fee provision, because as I understand it, there is now a fairly significant fee that is going to be associated with import tolerances, and as I understand this rule that import tolerance would automatically be established under a Section 18 provision any time that it's granted for a particular commodity in the U.S. under Section 18, which without a fee being associated with that, and if you want to talk about fudge factors, it's not going to be use of a product after the expiration date if you're looking at those as potential revenue sources. I would suggest that that half a million dollars per represents a much more significant fudge factor potential of abuse of the Section 18 process than some other issues. I'll leave it at that.

You will get significant comment from both the Minor Crop Farmer Alliance, Florida Food and Vegetable Association, and other of the minor crop community, because we were extremely interested in this process and have been dealing with it directly for 15 to 20 years and do see some need for some of the eight proposals to be at least discussed more fully and put out on the table, not that we would recommend all eight or concur with all eight, but there are some very significant issues that need to be dealt with there that could streamline and make the whole process better and more appropriate than is currently being utilized.

MS. MULKEY: Thanks, Dan.

MR. BOTTS: I would like an answer to the question on the import tolerance issue, but at least your perception -- if I'm reading it wrong, I'd like to know that I'm reading it wrong.

MS. MULKEY: I would want to sort a little bit. I mean, when we set a tolerance for Section III, that's also an import tolerance, so I'm a little unclear about

-- maybe we could talk to you off line and try to understand exactly what it is you're trying to poke around, and then maybe we can try to give you a clear and more complete answer.

MR. BOTTS: I'm more concerned with the crisis exemption provisions, because as it's written right now, it takes the crisis provision, exemption provision totally out of the hands of being a mechanism that's usable unless there is already a tolerance in place.

MS. LINDSAY: Can I just say one thing? There is, Dan, a small discussion in the preamble of the crisis issue. It doesn't go into it in elaborate detail, but it gives a hook for comments.

MR. BOTTS: I'm just saying the way it's written right now, you've excluded it from being any kind of tool to use to deal with emergencies.

MS. MULKEY: I think we understand that issue.

MS. LINDSAY: I understand the issue. I'm just trying to say we're aware of the issue. We tried to at least surface it by the preamble discussion, and I am ecstatic to hear about your comments.

MS. MULKEY: But especially if you have specific suggestions about how to address that. I think we're receptive to them. We aren't dismissive of the problem at all.

MR. ELWORTH: Can you clarify the situation for import tolerances under an 18? What is the current provision for paying a tolerance fee under Section 18?

MS. LINDSAY: The current tolerance fee system doesn't cover Section 18's.

MR. ELWORTH: Okay. That was my understanding.

MS. LINDSAY: In the future any new one that we establish will.

MR. ELWORTH: But would there be an associated fee for the import tolerance that is established --

MS. MULKEY: I think part of the problem is there is no such thing as a separate import tolerance when there is a domestic tolerance. So when we say it's an import tolerance, what we mean is once there is domestic tolerance, imports are legal, which is a little different from there is an import tolerance. So I think that's part of the confusion, which is why I sort of begged the question to try to get some. I think we have sort of a language thing.

When we use the term import tolerance, we mean there is no registered domestic use, and so the only reason tolerance exists is to accommodate imports. Otherwise we just use the term tolerance, and there is a registered domestic use or a Section 18 or some authorized domestic use and as it happens, imports can carry the residues if they are within that tolerance. So I don't know if that helps or not.

MR. ELWORTH: It will come up later this afternoon.

MS. MULKEY: Okay. Warren and Bill, and then we're very close.

MR. STICKLE: CPDA and ISSA yesterday had a day long workshop on tolerance fees, and we really appreciate the EPA's participation and Carol did an excellent job in presenting the issues. It was a very good dialogue, and I think raised a lot of issues, and I want to just touch on a couple of them concerning inerts.

There is going to be a significant, and I think widespread impact of the tolerance fee proposal on inert manufacturers, on antimicrobial producers, on the new food additives, the hard surface food contact sanitizers that are going to be added to this list. It's going to have a significant impact on small businesses as well as large businesses and may force some of the basic agricultural chemical manufacturers to reformulate a product if you lose a number of products.

I think you also have to look at the severe impact that you're going to have on the farm community, the ranchers, the consumers and the users as you pass along $28 million in fees to everyone. So the net result, I think, is that there is a significant impact that really needs to be assessed and looked at.

I'd just like to comment, though, on the inert industry and the discussions that were developed yesterday. On the 40 CFR 180.1001 there are probably about 123 inerts that are on list A, and another 703 that are on list 3 and 4-B, et cetera. The bottom line on that is that if you take the reassessment fee of $79,300 and multiply it by those 703, you're looking at a $55.7 million fee.

Now, the ag chem industry is roughly about a $10 billion industry. The inert industry on the otherhand is about $100 to $125 million as opposed to billion. So the inert industry is about two percent of the large ag chem industry. In recovering costs, the agency has pointed out they are trying to collect about $20 million additional each year, 4.7 million of which would come from the inert community.

Now, what we're really talking is two percent of the business paying 25 percent of the fee, and that just creates, I think, an unequitable situation. The result I think is going to be a loss of a lot of inerts, whether it's 25 or 35 or 50 percent of the inerts, I think we're going to lose perhaps a significant amount of these. We have several companies stating yesterday that since the inerts are not (the agricultural chemical products) are not the major focal point of their interests, that they will in fact pull out of the ag chem industry and sell it into shampoos, sell it over seas, sell it into the ag chem market over seas to the disadvantage of American farmers.

So what we're really looking at is the cost and the impact that this is going to have. The thing that I guess was concerning me the most is when you looked at the assessment that the agency was looking at, they made an assumption that they would not lose a single inert product as a result of this $79,300 fee, and I guess I just find it difficult to believe that we're not going to lose hundreds of these types of products.

And I think the impact there is going to be widespread. It has a ripple effect across the economy as far as jobs and trade, but it also has more importantly an impact on creating new incentives or lack of incentives to create new products in the area of inerts. And I know time is really short, and we're trying to get to the lunch hour, but I just wanted to touch a base with you and call to your attention the impact that the tolerance fee proposal is going to have across the board, but particularly on those who make inerts that are used in food use chemicals.

MS. MULKEY: Well, one of the reasons why we have a proposal and workshops like that is so the expertise that your industry can offer can be considered by the agency, and I assume that other stakeholders here were pleased to learn a little bit about the thrust and the basic content.


MR. McCORMICK: Yeah, just a couple of quick questions for Jim on these fees. I'm a little concerned when the point was brought up about how you may staff this function, that you weren't sure whether it was going to be drawn from FTE's or from consultants or anything, and I'm wondering if you -- if the cost that you've already thought of here were based on FTE's, and you don't know if you're going to do consultants, I wonder if you're fairly costing out, you know, depending on the option.

I'm also concerned that if it -- that it does draw resources, if it becomes an FTE issue, you know, I really think you need to think out before this thing gets passed, whatever, how this would really be implemented or the impact from a staffing provision.

And I also have a question about whether or not

-- what impact this would have on the priority list that you gave us earlier today if you're running from three to five years down to 22 months for new actives, where do these fee for service actions, where do they start playing in a priority list?

MR. JONES: On your second question, which is much easier, under fee for service, time would dictate priority submission time. To the extent that two things come in at the same time, you can make choices, and we'd probably use the system as it is now to help us make those choices. But the goal is the goal regardless of your -- whether you're a methyl bromide alternative or a registrant priority and nothing other than that. So the priority system becomes less relevant to choices. It would be much more narrow in terms of how it plays out.

When we costed out the fee for service process, we did so calculating basically using the existing FTE contract allocation, and so it does have inherently built into it this assumption that you'd sort of maintain that basic allocation. However, we will have the flexibility, if it does go forward to within the cost constraints, to think about reallocation of that in a way that may be more logical, cost efficient.

I certainly wouldn't pretend that the current approach is the most efficient possible, and there is no improvement for it and changes certainly could be considered if this were to go forward in that allocation.

UNIDENTIFIED MALE SPEAKER: Just to emphasize again, I mean, those decisions have not been finalized obviously, because the thing is not even at bill right now in terms of being introduced, and we would be -- we are more wary than you probably, on sort of having people who are either the wrong skills five years after or just the wrong sort of mix of, you know, in-house versus contractor kinds of folks. And they have been costed out and it's been talked to with the industry in terms of the kind of manpower needs and also the costs associated with that. Those are all pretty much government standard stuff for EPA and our budget.

MR. McCORMICK: I think my concern as a non-ag registrant is that we hear fairly constantly that our action is being postponed due to some emergency or some ad priority either for that chemical or some other thing coming on, and this just becomes another reason if you're cutting into these FTE's, you know, in the standard day to day business, you know, I'm nervous that I'm going to hear yet another reason, which is, well, you're not a fee for service registrant, that's why your action is being delayed, and I certainly hope that's not something I ever hear.

MS. MULKEY: The hope, of course, is the contrary that some of your competition for appropriated resources will go away and that your capacity to get your share of those will --

MR. McCORMICK: And that's why the vagueness of the execution was my concern.

MS. MULKEY: I don't want to leave the impression that the nature of your dialogue is not the most important thing to us, it is, but all of us are dependent upon the clock working for us through the course of the day. I don't want to neglect calling on Shelley, however, but we'll call on her with the mindfulness that we do have time constraints.

MS. DAVIS: I just have two questions, and I just have to preface it by saying that I share the concern that Section 18's have taken over too much of the resources and become a subsystem for registration. Has the agency gone back and looked at instances in which Section 18's have been denied to determine whether there really was an emergency, whether the denial was appropriate, whether there really were economic losses to evaluate how these criteria really play out, and I raise this in particular in light of some of these recommendations, because these recommendations ask for, say, flexibility in the definition of emergency or economic loss, and those are issues that a retrospective analysis of how well you've done might give you some clue as to whether this is necessary or not.

MR. JONES: Not systematically we have not done that kind of a retrospective. We have had a couple of situations where it very quickly came back to our attention, because it really was an emergency, and actually at a PPDC meeting -- and we didn't deny that one on the basis of an emergency, though. But we had a PPDC meeting where we had a denial and the growers actually flew in for this meeting to tell us how bad their emergency was a couple of years back. But we have not done a systematic retrospective on how well our denials recently, Anne Lindsay a former director --

MS. LINDSAY: I didn't do anything different than Jim did in that regard when I was in charge of the process. I was just going to mention, Shelley, that the performance audit that Jim talked about earlier I think to me may be the most exciting recommendation from NSDA and APCO, because it allows us to examine the overall functioning of the Section 18 program from a number of different perspectives and the issue that you're raising is one of the issues that could be easily looked at as part of a performance audit. And I think it would be a valuable thing to consider.

MS. MULKEY: Is that the last word, or did you have a --

MS. DAVIS: A 30-second question. I was wondering what a quarantine exemption is, and I was suspecting that it was a re-entry interval exemption. I was wondering why that got three years?

MR. JONES: No, quarantine exemptions include treating commodity coming into the United States because there is concern that it's infested with some non-indigenous bug. It includes the med fly programs in Florida and California where generally the petitioner is actually the USDA, aphids. It's those kinds of exemptions.

MS. DAVIS: So it's not a worker issue at all?

MS. MULKEY: Right. Well, thank you all. This has again been a particularly meaty discussion. Let us try to reconvene at 1:05. That really squeezes us, but let's not sacrifice the rest of our schedule to our morning difficulty.

(Whereupon, a luncheon recess was taken.)













MR. MCNALLY: The first thing I want to do is talk about tolerance reassessment, and I have about five or ten minutes of remarks, and then we can take some questions and comments at that point, and then after that I guess we can turn to import tolerances if that's okay with the group.

MS. MULKEY: Actually, if you'll allow me to override you.

MR. MCNALLY: Do both.

MS. MULKEY: Do both, and that way we don't lose the second one to the first one.

MR. MCNALLY: Okay. What I want to do with tolerance reassessment is three things. First I want to summarize quickly some key points about tolerances as I think most of you know. So we'll go through that pretty quickly, and also some key points on FQPA as it relates to tolerances.

Secondly, I want to review how we've organized our work to do tolerance reassessment, and third give you an update on how we're progressing. Let me also say that the gentleman turning the slides here today is Dan Helfgott. And in addition to being just another pretty face under that beard, he's also been one of the managers of our tolerance reassessment program, and has been instrumental in getting us to this point.

So without further ado, let me just go through quickly a couple of slides. Those of you who worked on this group have heard the term tolerance used before, and essentially that's the maximum level of pesticide residue allowed on food.

Now, the next slide talks about what emission is with respect to tolerance reassessment under FQPA, and essentially what this boils down to is there is some new requirements that we have to adhere to for risk assessment under FQPA in assessing tolerances, and also another point I want to make here is that the mandate was for us to reassess all permanent tolerances that were in effect as of August 3rd, 1996, and that's over 9700 tolerances. So temporary tolerances or new tolerances after August 3rd, 1996, aren't part of this group of tolerances that need to be reassessed.

The next slide talks about some of the key deadlines, and I'll just draw your attention to the first one. When I first took this job, I looked at the new law, which is two and a half years ago, and I said, August 3rd, 1999, well, that's way off into the future, and I think this is just an indication of how time flies when you're having fun, because in just another couple of weeks, we'll be at that important deadline.

And by that deadline, we have to have reassessed 33 percent of the tolerances that were in existence as of August 3rd, 1996. Now, in terms of the priority, the law was specific that we needed to give priority to reviewing those tolerances that appeared to pose the greatest risk to public health.

And I want to thank this group, because you were very instrumental in giving us some assistance a few years ago in helping to sort out the tolerances into the three priority groups that appeared in the Federal Register of August 4th, 1997, another important milestone in FQPA that we met.

Let me refresh your memory in terms of the groupings that we came up with. Priority group one are some very familiar chemical families I think most of you are familiar with. We have the OP's, the carbamates, the organochlorines, the carcinogens. These are in priority group one, because they appeared to us to pose the greatest risk to public health.

Now, priority group two consists of remaining C carcinogens. These are possible human carcinogens, and then any remaining reregistration pesticides that were registered for 1984. So that's essentially group two.

The third group consists of the biological pesticides, the inert ingredients, and as you see these chemicals by their very nature are going to be ones that are generally deemed to be safer, and so that's why they are in group three.

Now, in your materials you'll see some pie charts, and let me turn to the first one and give you a sense of how the tolerances break out by each group. You see on the pie chart that there are over 5500 tolerances in group one. These are the ones that we considered potentially the greatest risk, and that's about 57 percent of all the tolerances. And then there are about 20 percent in group two and 23 percent in group three.

I guess an important point here is this is not divided up one-third, one-third, one-third, but we took all the high concern chemicals, put them in group one and then added up the tolerances, and that --

(End of tape.)

MR. MCNALLY: -- and then the other category consists of the inerts and some of the orphan, quote, unquote, chemicals that don't have a particular family member they are associated with. So that's sort of an overview of how those tolerances break out.

Let me come back now to FQPA on the next slide, and talk a bit about the different requirements, and again, this is old hat for most of you. There are four things we have to look at. Aggregate non-occupational exposure, drinking water, dietary exposure, residential, the cumulative effects from pesticides with a common mechanism. The increased susceptibility of sensitive populations needed to be examined in doing the tolerances, and lastly we needed to be concerned with any endocrine effects.

I wanted to highlight specifically what the law is in terms of how we're considering reassessments completed. How we're approaching that in the program, and it's really two ways. A safety finding is made is the first way, or a tolerance is revoked. So those are the two ways we would count a tolerance as being reassessed.

So let me give you a sense of how in the program we've done that, and really it's been a group effort. The reregistration program has had decisions made. Reregistration decisions are called REDs. And this is an in depth review sort of from soup to nuts of all the issues associated with the chemical, and these are the chemicals that are generally older chemicals before 1984.

The registration program that Jim Jones manages also is a way to reassess tolerances, because as you see on the slide when a new use comes in for an existing chemical, we have to make sure that the existing uses meet the FQPA standard in order to see whether that additional use is allowed. So in terms of reassessment, if there were 20 uses that previously were in existence, and a new one wanted to come in, if that was okay to do, those 20 older ones would be reassessed at that point if it was acceptable to add the additional one.

So I want to highlight that's a reactive process, because as these new uses come in, we deal with them as they come into the agency.

The third way is through tolerance revocations after domestic uses are canceled. So if someone cancels a domestic use, we'll see whether there is an interest for an import tolerance. If there isn't, we'll go ahead and revoke the tolerances. And I might add today in the Federal Register there are, I think, four separate notices that are announcing the revocation of several hundred tolerances through this process.

Now, let me do the third thing I mentioned. I want to give you sort of an update on the score card on how we've done thus far. As of today, we've reassessed 3140 tolerances, which is 68 short of the number that we have to reach by August 3rd, 1999, to fulfill the requirement in FQPA to reassess 33 percent of the tolerances by that date. So we're almost there. We're not there quite yet, but we're confident that we'll reach there in the next few weeks.

Now, let me give you an overview of how those reassessments that have been done to date break down by the three programs, registration, reregistration, and the tolerance revocation process.

UNIDENTIFIED MALE SPEAKER: Excuse me, Bob, do we have this paper or will we have it?

MR. MCNALLY: I think you have most of them. There is one slide that is not in there that we put out on the table, but we can get it if for some reason you don't have it. I think there was a condensed version that was put together to save space, and so it may look a little bit different, but we'll certainly make sure each one of you have it.

And this is just a score card by the programs. As you see, registration and reregistration have made roughly the same number of safety decisions, and have accounted between them about 57 percent of all the work, and we've also had FR revocations to the tune of about 40 percent of the work thus far. So that's how the program has broken out by those three groups.

The next slide will illustrate how the reassessments have been done by each group, group one, two, and three. I think the important message here is that two-thirds of the reassessments done to date have been from group one, the group where the tolerances that appear to pose the greatest risk reside, and the other third come from group II and group III.

The last slide for tolerance reassessment, I just want to give you a sense of how -- what's happened as we've reassessed these tolerances. As you see from this, approximately 45 percent have been revocations. Approximately 47 percent have remained the same, and a handful have gone up, and a handful have gone down.

UNIDENTIFIED FEMALE SPEAKER: I'm sorry, this is the slide we're missing?

MR. MCNALLY: That's the one you're missing and it's out on the table, and we did it in a large format for you. So we'll make sure you get that.

So let me just summarize this. I think the three points I'd like to make, first we appreciate the help that this group provided in setting up the program initially to divide the work into those three groups. Secondly, I want to highlight again, we've reassessed roughly two-thirds from group one of the total that we've done, and the third point is that we're not quite there yet in terms of getting to 33 percent, but we think we'll be there by the August 3rd deadline. Okay. That's it for tolerance reassessment.

I have about five or ten minutes of slides on import tolerances that I wanted to cover. First before I put any slide up on this, let me just say that there is an old adage that no news is good news, and for the most part 90 percent on what I'm going to tell you on import tolerances is old news in that this has been EPA's policy for quite a while. And the point I want to make is we're going to publish our import tolerance guidance within the next several months, and so I wanted to highlight some of the key aspects of that, and also call your attention to some new ideas that we wanted to bounce off this group today.

So let me start first with the 90 percent that isn't really changing, and that's the import tolerance guidance specifically. What import tolerance is is simply a tolerance that exists when there is not a U.S. registration. So if there is some exotic fruit or vegetable that's grown in another part of the world that's consumed by Americans, there certainly wouldn't be a registration in this country, but we'd need to have a tolerance for that, because the American public would consume that fruit or vegetable. So that's what an import tolerance is.

There is no distinction in an import tolerance or between an import tolerance and a tolerance that exists when there is a domestic registration. They are treated the same. And the third point is is that the standards under FQPA and FFDCA, they all apply the same to tolerances across the board whether it's domestic registrations or import tolerances.

So let me cover for you quickly the purposes of putting this guidance out that you'll see probably in the next couple of months. First, we thought it was important for transparency sake that people see this guidance. We've used it for a number of years, but we thought it important to put it in writing. And, secondly, there are many people who need this guidance to really comply with FQPA, because as we proposed to revoke some tolerances, some people have expressed a willingness to support those tolerances for import purposes.

So we also want to illustrate with this publication how FQPA affects this whole concept of import tolerances. And the third reason is that we're using this effort as a stepping stone towards a NAFTA policy on import tolerances. So the U.S. has developed its own that accommodates the NAFTA interest, but eventually we're going to move towards a NAFTA policy with our colleagues in Canada and Mexico.

The last point -- I've now covered the 90 percent. The last point that is a little different is that we wanted to get comment on our plan to require information about pesticide use and residues in imported commodities where there also is a domestic registration. So this is a situation where there is a registration in this country, but there is also imported commodities coming in. We wanted to get a better handle on that imported commodity aspect. And at the end of my presentation, we'll cover that in a little bit more detail.

Real quickly, the data requirements for import tolerances are essentially the same as they are for domestic. There are a couple of obvious differences. We don't get any information on occupational exposures since this is an import issue. We don't get any information on some of the environmental issues that we would for domestic registration, because it's an import issue. So without further ado, I think, those are the main differences both on the toxicology and also on the residue. I would comment on the residue one and highlight an important part, which is the last bullet you see there.

As the significance of an imported commodity in the U.S. diet goes up, we're going to require more field trial information about that particular commodity, and that's sort of logical as you think about it. Let me just illustrate for you on the next page with a quick example of how that relates to oranges.

For domestic registration in this country you would need 16 field trials for a tolerance associated with a U.S. registration. We know that averaging this out over the past four or five years, about 21 percent of all our orange products come in from overseas. And so in our guidance we have 12 field trials that would be required for an import tolerance if the pesticide would be marketed everywhere but the U.S.

I think the point there is the comparability between 12 and 16 to get a sense of the flavor of how we would treat imported commodities.

Last, but not least, in terms of the import tolerance policy itself, I wanted to cover a quick couple of points on Codex. Codex establishes international food standards including what are called maximum pesticide residue limits or MRLs. And I think the point here is that we tried to accommodate studies done elsewhere, Codex and elsewhere other countries, but the bottom line is the U.S. reserves the right to look at the data itself in making these decisions. And so it's important that the second point there is that FQPA requires of us to provide a justification when we deviate from Codex when we are establishing a tolerance. So that's something that's written into the law itself that alludes to the Codex effort.

Okay. And now I'm turning to that last point I mentioned at the beginning about how we treat imported commodities with domestic registrations. This is a new approach we're considering that we think has some value. Currently when we do our work, we assume that residues and imported commodities when there is a domestic registration will be the same as the domestically produced commodities. And so we don't know if this assumption under or over estimates the risks, but it's an assumption we make, because we don't have any information on the imported commodities in terms of the residues. What we're suggesting here is in limited instances, we would permit greater consideration of those residues on imported food coming in from overseas.

And let me just illustrate for you the conditions we think would be relevant to apply this type of effort or this requirement, and they would be threefold.

First, if there is a high percentage of the commodity imported into the country, and the example we use there is bananas, it would seem to make sense we'd want to get a better handle on that.

The second reason would be if we felt that the domestic residue data in some ways were not representative of the data or of the residues from overseas, different growing conditions, different climates, those sorts of things, it might be prudent to get information from those locations. And lastly, if we felt in some way that U.S. consumers could be exposed to significant residues in imported foods, that would be a reason to get more information.

So to conclude, the import tolerance policy proper deals strictly with those instances where there is no domestic registration. What we're talking about here is a little different. There is a domestic registration, but there is imported food coming in, and we want to get a better handle on that food, and that's the area we're looking in particular for some feedback for.

So with that, let me turn it back to Marcia.

MS. MULKEY: Okay. Well, these are two topics that I assume both have their capacity to encourage you a way in. So, again, we'll try to play by the rule of not trying to separate the two. Have folks able to participate on either, and see if that works. If we sense that there is something wrong with that dynamic, we can make a mid-course correction. No takers, no flags?

MR. CARRASQUILLO: (Inaudible) -- each are on the Codex. In November of this year, there is going to be a second run on the WTO agreement on agriculture, and it is my understanding that that is going to be revisited. It is possible -- it is my understanding also that environmental and workers' conditions could be included for the new round, second round of the agreement.

MR. MCNALLY: Interesting. Fred Eisers (phonetic), who our person who works in that isn't here, but that's something I had not heard.

MS. MULKEY: Do you want to speak to that?

MS. LINDSAY: I'm not as informed, Nelson, as I'd like to be, but I do know that there is some discussion that other kinds of issues, such as the ones you've mentioned may be part of the discussions. So it's something we could probably report back on at some point.

MR. CARRASQUILLO: The point is it has to be ratified, you see. So it is my understanding that the U.S.A. has not signed in to the workers on environmental conditions. Do you see that as a possibility to be included as part of the agreement, to be recognized as part of the agreement.

MS. MULKEY: Maybe we could see what we know and provide that information.

UNIDENTIFIED MALE SPEAKER: Could I maybe make a clarifying comment on that?


UNIDENTIFIED MALE SPEAKER: The world trade organization agreement is, I think, up for some further discussion, and I don't pretend to be knowledgeable about that. I know somewhat more about Codex.

Codex I think is important simply because the existing world trade organization agreements refer to Codex as kind of the setting, the template for international standards for foods that are traded internationally. I think there will be a lot of discussion around a lot of issues within the world trade organization discussions. I don't think there is likely to be much discussion about changing the WTO's recognition of Codex.

Let me go on to say for those of you who are not knowledgeable about Codex that at the end of June the Codex Commission held its big meeting in Rome, and at that meeting Tom Billy, who is the head of FSIS, was elected as the international commission chair. So the Codex chair is now with the United States for at least the next two years, and that -- but Codex predated. I mean, it goes all the way back to '62, and I think it will continue to function pretty much the way it always has independent of the World Trade Organization discussions.

MS. MULKEY: Thank you. I've gone one way and the other way, and I'm going to take a bouncing around, which I may regret. I'm going to try by calling on Carolyn next.

MS. BRICKEY: I guess in reviewing this information that you gave us about import tolerances, while I just have kind of a basic question, my original understanding of the import tolerance was that basically you were granting them for crops that weren't grown in the U.S. in an appreciable amount, like bananas. Is that now expanded to other types of crops like oranges, where you would allow oranges to be imported with residues from pesticides that you wouldn't approve here?

MS. MULKEY: Let me take a crack at that. I don't think the test is whether we would approve it. The standard is the same, but if it is not, in fact, registered here, perhaps registration was never sought, perhaps registration was abandoned, but not based on our making of finding that it was, you know, didn't meet a safety standard, then there has always been, as I understand it, the option of a petition for a tolerance for pesticides that's not registered here. But then if we got such a petition, and we have some pending. Jim mentioned them this morning.

We would do the same analysis as if it were a petition to register it and get a tolerance here with the exception of not looking at the worker issues and not looking at the eco impacts. But we would look at the same dietary, potential impact on drinking water, reach the same FQPA safety finding, but yes, it's entirely possible that a product not registered here would be the subject of an import tolerance, and we get --

MS. BRICKEY: So if there is a pesticide you wouldn't register because of worker risks, you might still allow an import tolerance, because you wouldn't consider that factor?

MS. MULKEY: That's a possibility, yes.

MS. BRICKEY: I think that's terrible.

MS. MULKEY: It has to do with who has jurisdiction over what risks. I mean, in the absence of a single world government, the host country has legal jurisdiction over protecting its workers, and we don't have any -- I mean, I don't want to say we don't have any, it would take some searching of authorities beyond the normal four corners that we look to think about our authorities.

MS. BRICKEY: What about if it were a pesticide you had canceled because of -- or use you had canceled because of the risk to workers here?

MS. MULKEY: Again, it would be a possibility. Canceled pesticides and pesticides where we've taken action based on risks, there is an international notification provisions. We get to some of that this afternoon, but under FIFRA there are international notification provisions, which require us to let the rest of the world know that we've taken action on this chemical so they can take that into account in thinking about their own approach. The notification provisions in FIFRA have been there for a long time. This new -- (inaudible) -- consent tree, which we have a briefing on this afternoon also in some ways expands and in some ways alters that dynamic.

Does anybody else among our group feel we need to -- those are good tough questions, but I think they have been pretty stable in terms of our approach to them for quite a long time.

MS. BRICKEY: I guess my point is that the use of the concept of import tolerances has broadened considerably since I've dealt with it. I just didn't realize --

MS. MULKEY: That's not the impression I have. My impression is that this is the way it's operated for quite a long time.

MS. BRICKEY: No, I don't mean you've changed your policy. I mean, at the time I first became aware of this issue, it was really limited to a few commodities that just weren't grown here, and I hadn't realized that it would be contemplated for commodities that are grown widely here, but also grown -- also imported.

MR. MCNALLY: Again, I think there is some, as I understand the issue here, the question we're seeking some comment on, and again we're sort of tripping over the words import tolerance, if a commodity is grown here and so therefore has a domestic production, therefore we have a tolerance under our system, we've not really looked separately at the fact that say 30 percent of that same crop comes into the country from somewhere else. And as much as we have sort of assumed it's the same number as our domestic growers use, correct? Everything has to be the same standard, but the question on the table now is we see more and more imported commodities is should we change any of that approach given this story position at the time.

MS. BRICKEY: Is there some international pressure on us besides political pressure that requires you to grant an import tolerance for something that might have worker risks that would be unacceptable here?

MS. MULKEY: We don't have to make it a priority that I know of as opposed to when we get to it, what's the standard that we --

MR. MCNALLY: Again, there have been no particular pressures, per se, as much as we face more and more of a globalized food market. So we're facing some more of these issues as time goes on. I mean, it's more that, the march of time and the dynamics of trade more than any particular acutely pressing kind of issue or chemical or anything else like that.

And at the same time, too, under FQPA we're getting asked by trading partners, governments or just major players who deal in the trade arena, what does this mean for me, how am I supposed to play. I'm happy to do whatever it takes, but what do you want, you know, what do I have to do.

UNIDENTIFIED FEMALE SPEAKER: Could I just add one point to the discussion, just a clarification, Carolyn, that in many cases when we seek import tolerances, it's because the, and I'll give you an example from our company, we have a fungicide that's registered on grapes for powder mildew control, which is a big problem in France, and in order to be able to sell the wine in the United States, or the champagne this is actually, we have to have an import tolerance on grapes. The market size for this particular use, it would be considered probably a minor use in the U.S., and we actually are pursuing registration in the U.S. now, but it was a low priority because of the size of the market, but in order to allow free trade, we had to begin with the import tolerance.

MS. BRICKEY: So you've already received an import tolerance for this use that you're talking about, but you would seek a registration here at some point?

UNIDENTIFIED FEMALE SPEAKER: And we are proceeding now to seek a registration, but it gets down to priorities. You can't do everything at once. So you tend to take your big markets first.

MR. MCNALLY: We didn't want a champagne shortage for the new millennium coming.

MS. MULKEY: Because this topic is -- (inaudible) -- Anne reminded me of something else I should have supplemented my remark about, we don't have to make it a priority. Our trade agreements do require us that we sort of be even handed. So we can't say we're never going to get to it, or it's automatically at the bottom of the list.

UNIDENTIFIED MALE SPEAKER: Just a quick follow up on this. You could cancel a use, revoke a tolerance and there could still be an import tolerance?

MS. MULKEY: Only if you reach the FQPA safety finding to preserve the tolerance. In other words, let's say you cancel a use, let's say for dietary reasons, then I think you'd be hard put to retain an import tolerance.

UNIDENTIFIED MALE SPEAKER: But if you were to cancel a domestic use for which made a significant contribution to the risk of the pesticide, therefore you cancel the use, revoke the tolerance for the domestic use, reduce the exposure, that route, you could still have an import tolerance on the books or an application for an import tolerance that would provide access to the pesticide to foreign producers.

MS. MULKEY: It's theoretically possible, but it would be an extraordinary scenario, and we have not yet faced that to my knowledge.

MR. MCNALLY: The foreign use provided one percent of the crop and the domestic use provided 99 percent of the crop, the use residues from that crop are what's causing a concern under FQPA could you keep that imported flow, theoretically, yes, I guess that's correct.

MS. BRICKEY: But the scenario of having a cancellation for worker or eco risks would be a more possible scenario.

MS. MULKEY: That's a more possible scenario.

MR. MCNALLY: That's more likely frankly.

MS. MULKEY: And could I just stick with my idea of bouncing around? I'll try calling on Ray.

MR. McALLISTER: One other circumstance where you might have an import tolerance is for a pest problem that doesn't occur here in the United States.

MS. MULKEY: I thought that's where it falls with this. I thought maybe this was just some french powdery mildew, but certainly we have it, too.

MR. McALLISTER: When you discussed a Section eight -- or let's see, the reassessment, the tolerances that have been reassessed, you mentioned that one situation that leads to reassessing the tolerances and registration action and new use, you reassess all the tolerances existing for that chemical, does that apply to Section 18 actions also?


MS. MULKEY: We have not been counting as reassess the review of the existing uses of 18's because although we had to make the safety standard, we have felt that the degree of rigor of our review was such that it was -- it would have been a little to --

MR. McALLISTER: One other question. You mentioned -- Jim mentioned earlier the rough time frames for approval of a new use or a new active ingredient in the three to five year time frame. Do you know how long it takes on average to improve an import tolerance?

MR. MCNALLY: It would largely depend on where and how long. Paula, we just did one for you a year and a half ago, how long did that one take?

MS. PAUL: It was -- I don't know the exact time, and it wasn't too bad, because it was already in the process before the priority system bogged down, but right now this is another example, because import tolerances do take a priority slot, and, you know, we certainly have a lot of debate within our company on the use of priority slot for an import tolerance, because ultimately the sales that result from that import tolerance approval don't go onto the books of the business manager that's in the United States.

So it really does take a global corporate view to when faced with a decision there to decide what to do, but I mean it is an issue. And again it gets back to, you know, what we really need to do which is find a way to provide enough resources within the agency so that you could do everything that you have in front of you and really have a system that works, because three to five years is just an impossible time frame from the business point of view. It increases the cost of development immeasurably, and ultimately the cost of the products in the marketplace.

So time is the number one factor in what it costs a company to bring a product to the market place. Data requirements and all of the millions of dollars we spend there pale in comparison to the cost of one year of a delay.

MR. McALLISTER: One last question. Are there circumstances where an import tolerance might qualify for reduced risk status?

MR. MCNALLY: Yes, but it has to -- we're going to look at the dietary risks only, because that's the only risks that Americans are going to be exposed to. So you need to show that the import tolerances reduce the dietary risks in the United States. It would mean comparing it to other pesticide uses globally on that crop that are being imported into the U.S.

MS. MULKEY: It's probably more theoretical than an actual.

MR. MCNALLY: We have not made a reduced risk on import tolerance, although we've been petitioned for it four times.

MS. MULKEY: Okay. Shelley.

MS. DAVIS: Two quick points. One on the tolerances that you've reassessed, in how many instances -- do you have any idea how many instances you've considered aggregate risks, which is to say actually in some way added together the risks from diet, food, residential or something else?


MS. DAVIS: I mean, I read azinphos methyl very carefully, and it was very clear that water was not added to food. So I want to know how often that happens.

MS. MULKEY: We haven't reassessed any of those.

MS. DAVIS: That's what I want to know. How many times have you really considered water and added it to diet.

MS. MULKEY: All of them.

MR. MCNALLY: Unless there was a revocation.

MS. DAVIS: I mean, they don't read that way. They don't read that way that you've considered residential. I just don't see that.

MS. MULKEY: None of the OPs have been reassessed through concluding that they meet the safety standard, none of them. All of the OPs that have been reassessed were through a revocation. So the reassessments where we added them all up were the ones we concluded met the safety standard. So it's the ones that came through the REDs or the ones where we were adding a new use to the registration process, and in every one of those, we actually used a very conservative value for most of them for water. We used the ones coming from the models, and we used our standard operating procedures to estimate residential. So in every one of those, there was an aggregate estimate of exposure.

MS. DAVIS: My second point, I guess I just would like to I think reiterates some of the sentiment that's been around the table on the question of import tolerances.

I think there is an issue of level playing field, and in here I think I am going to be agreeing with the folks around the table who are growers that if they have to abide by safety considerations to workers or ecological risks, they are being put at an unfair disadvantage if the import tolerances don't have to pass the same tests, and then it just rebounds to the disadvantage of the workers here.

So I really think you should consider the level playing field aspect and at least in terms of ecological risks, I think it's pretty short sighted to think that ecological risks in Mexico or Canada don't impact on the United States. I'm sure they do.

MS. MULKEY: I think if you have suggestions about either legal tools or analytical tools that would approach that issue, I think we'd be receptive to listen.

Should we go to Phil?

MR. BENEDICT: On the import tolerance issue, I assume that you issue import tolerances occasionally for things where there is no food use in this country, but there are registrations that are valid in the non-food use arena in this country. I'm guessing that's a big part of what you're doing. They are not all brand new chemicals. In that light, how are you dealing with the aggregate exposure risk situation?

MR. MCNALLY: I know we've done some import tolerances in the last two years where there were registered uses, food uses in the U.S. They were seeking to add new use but just for import purposes, and in that situation, we have to make -- whenever we set tolerances and make the FQPA safety findings, we're going to add all of the exposures allowable in the United States, dietarily, water, residential with the then risk in the import tolerance. I'm pretty sure we did one just this past year. I can't remember. There have been plenty of U.S. food registrations, but they wanted one import tolerance for a particular use.

UNIDENTIFIED FEMALE SPEAKER: Could I add something? I spent some time looking at these issues for different reasons than Jim. Most of the ones that I'm aware of -- most of the ones, Phil, that I'm aware of we've either got other food uses already registered, but it's a situation like Paula described where either the market is very small or the pest just doesn't exist here. So that you get this more free standing request to approve a tolerance for that foreign commodity, or there are occasionally whole chemicals that get an import tolerance, because for whatever reason in the past the manufacturer decided there just wasn't a market.

But probably the most infamous of those was prosimedone (phonetic), where it was used extensively on wine grapes everywhere but the United States, and there was no registration at all. So that you get this sort of loan import tolerance. I'm not aware of so many where you've got non-food uses in the U.S., and then an import tolerance for a food use from elsewhere, although they could be in there. But it seems to me like the vast majority are for food use chemicals, but that use is either not large enough to be of immediate interest in the U.S., or it's just not relevant because the pest is very different.

UNIDENTIFIED FEMALE SPEAKER: And indeed most countries now, particularly ones that export grapes to the United States, Mexico, and Chile, that you cannot market a product. It goes through the registration process including a worker safety assessment in the country where it's registered, but they will not really allow it's use until it has a U.S. import tolerance.

MS. MULKEY: Jacqueline?

MS. HAMILTON: Just following up on that, do I understand, I'm just a little concerned about the exchange earlier about this issue of could something that did not meet the FQPA safety standard here and had that tolerance canceled still have an import tolerance. And the thing that I'm concerned about that I think I heard said was it might still be allowed because it was a tiny percentage of the market, and therefore it would be the fact that we consider percent of crop treated that would make it possible. Am I misunderstanding?

MR. MCNALLY: For example, if something had wide use in the U.S. and one percent of the crops imported, theoretically -- and it comes in at 102 percent of the risk, by removing all domestic production for whatever reasons or that's what the registrant decides to do, reduces the FQPA analysis, you know, such that it is acceptable, it is theoretically possible that the imported part of that goods stay on theoretically. So it's not changing the standard. Everything has to meet

-- the fundamental starting point on tolerances, tolerances are at the level playing field. They are the same for imported and domestically grown commodities. They have to meet the FQPA standard.

MS. HAMILTON: Thanks. I just wanted to get clear on that. I'm a little unclear on one of the things raised in the presentation about the guidance, and that is this issue of, you know, now beginning to acknowledge that there may be different levels of residue et cetera on food coming in. And, you know, Consumers Union did a study earlier this year that showed that, in fact, it's a very mixed bag and sometimes the residues coming in on imported foods are actually lower than domestic foods. So I'm not, you know, trying to impugn imported foods at all, but I'm a little confused about how you would even know is it the case that there is no -- what I'm trying to ask is about monitoring. How would you know whether or not U.S. consumers in the third of these bullets would be likely to eat higher residues on imported food. Is there no separate monitoring of imported food to figure out residue levels?

MS. MULKEY: Let me back up and try to explain what this policy is about, and then we could try to tackle the issue of what we know from monitoring. This policy is basically focused on the stage at which you're setting tolerances. And the stage at which you're setting a tolerance, there isn't -- the residues aren't in the food. You can't go into the market place and find out what the residue levels. You can't stop food at the border. It's not supposed to be there at all.

And at the stage where you are setting a tolerance, what we do, as you know, is we have what we call field trials. So you apply the pesticide in field conditions, and you try to learn, you know, you try to learn what the likely residues are associated with a given rate and field conditions. And one reason why we require multiple field trials is we want to see them under different growing conditions, different parts of the country, different climatic conditions.

What we're exploring is whether in addition to understanding all the variability within the United States that might affect what kind of residues you'd expect when you apply it, if a significant portion of the crop is imported, and if this chemical is also going to be used abroad, wouldn't you also want some feel of whether, you know, subtropical conditions or very different conditions abroad or different practices might lead to different residues. So this policy is focused on what kind of data are produced at the threshold to help you understand what tolerance you should set and what your expectations should be about residues.

Now, the harder question, which is when you're doing a risk assessment based on monitoring data, which is where we're moving for our more realistic risk assessments, whether you need some ability to distinguish between imported and exported food and whether that's important in analyzing, I think is a whole different set of questions, which I think there was a little bit of confusion in terms of how we talked about it.

The field trial data help you understand something about your risk assessment, too, and we use them, but mainly they help you analyze the risk going in before you have a market basket to look at. I hope that helps in terms of sorting through.

MS. HAMILTON: That would be glass getting clearer. Given what you just said, though, Marcia, why would you then want to require fewer field trials rather -- the 12 instead of the 16?

MS. MULKEY: We're talking about an additional 12.

MS. HAMILTON: An additional 12 --

MS. MULKEY: It would depend on the -- let me back up. That may be too complicated for me to try without Fred. It's -- we try to require no more field trials than we think are representative, and what we're trying to say is if you're talking about an import tolerance, where you don't have any domestic use, how many field trials is the functional equivalent of the amount we would require for a full domestic is a function, we think, in part of how much of the commodity is imported. That's that idea, and that's what we're seeking comment on. It's debatable.

MS. HAMILTON: So taking 16 field trials is because you feel that's representative of the geographic diversity of the United States?

MS. MULKEY: Among other things.

MR. MCNALLY: Chris is here.

MS. OLINGER: I'm Chris Olinger. I'm in the Health Effects Division, and I've been involved in the development of the guidance. What we started with as a basis was our current 860 residue chemistry guidelines, and that's where the 16 field trials as a requirement came from. Those 860 guidelines have been to our scientific advisory panel, and that's already well established.

MS. HAMILTON: But the rationale for the 16 is --

MS. OLINGER: Is based on the amount grown in the United States and also in the relative significance in the diet. When we establish the original basis, if a food was very important in kids' diets or very important aspect of the U.S. diet, we actually required more field trials than our original standards that we set up on the basis of acreage.

When we went to start developing the number of trials for import tolerances, we used the same principles with regard to production and with regard to significance in the diet particularly for children. In the examples, if you look at the entire import tolerance guidance, which will be coming out in September, what we've done is that if about half of what's consumed in the U.S. is grown elsewhere, then we require an equal number of field trials for an import tolerance as we would for a tolerance covering a U.S. registration. And so on and so forth.

For the commodities where most of what is we consume in the U.S. is imported, the number of field trials is based on the importance in the diet, and we also consider sensitive subpopulations such as children.

MS. HAMILTON: So like bananas, where a kid is likely to eat a lot of bananas?

MS. OLINGER: Bananas, yeah, we require 12 field trials for an import tolerance for bananas. And if someone is seeking a U.S. registration for bananas, they only require five field trials. So this is actually somewhere where we do more.

These import tolerance guidance lists were taken to the SAP in June of 1997, and they basically blessed our methodology for determining number of field trials.

MS. MULKEY: But we are also going to put this policy out for comment. So there will be an opportunity for folks to engage if they --

MS. HAMILTON: Just to finish up, last thing I'm going to and I'm going to stop beating this horse. This is all largely around page 11 of these slides, this new approach that you're proposing, additional data on imported commodities will be necessary when domestic residue data are not likely to be representative of grower conditions in other countries. How will you know? You'll know from?

MS. MULKEY: We do have more detail in the proposal, but the idea is just to obtain some screening information from the registrant about growing.

MS. HAMILTON: So you're going to seek that information. It's not based --

MS. MULKEY: Right. We have a data base we can go and learn that from.

MS. HAMILTON: Thank you.

MS. MULKEY: We can also deal with countries involved. The threshold will basically become part of the application if we go forward with this.

We're still within the hour, but we're past the time we would have been finished if we had started on time. But Beth, did you give up?

MS. MarshallL: Actually the air conditioning --

MS. MULKEY: Okay. We'll call on you next then.

MS. MarshallL: I'm just going to second Shelley's comments about the level playing field, and I think it's very important to remember that producers are in some cases at least, possibly not for bananas, competing against producers, and that I also found it interesting that for commodity, which is as large a percentage of the U.S. diet as oranges and orange juice, for instance, that you're requiring less testing than you would for a tolerance associated with U.S. registration, even though it is only 21 percent are imported. That's an extremely important part of our diet and children's diets in particular. I don't quite follow the logic of not requiring an equal testing procedure.

MR. MCNALLY: The first -- (inaudible) -- process we identified if it's a nationally grown crop in the U.S. given the diversity of our agricultural production system here is X field trials.

(End of tape.)

-- may or may not be big. I mean, that would be the kind of thing that dictates whether it's 12, 6, 18, those are the kinds of questions that come up, and the 12 versus 16 is not sort of an absolute kind of indicator of relative importance or contribution or anything else. It could be that all of the imported commodities come from one specific region, like if X percent of our grapes come from Chile for some part of the year it may only be a very narrow region, we'd want that kind of field trial data for that, call it a niche, a hydrogeological niche kind of place.

So in that case, it may be appropriate for us to feel confident in our analysis to do less than 12 or whatever. If it was a world crop coming from all over, you might even want more if all of it was imported, and it was imported everywhere from Asia, South America, and Europe, but not made in America, you might want to do more. That's the kind of notion underneath it.

So again, I think from some of this discussion that somehow it's a meaningful of 16 versus 12, 16 plus 12, you know, one half of one, one half the other. The idea underneath it is how to get -- is to get some representation of the places where we think the food could be coming from, because particular growing conditions might vary such that we'd want to know about those differences.

MS. MULKEY: One of the problems may be that this presentation was designed, of course, to be at the 30,000 foot level, and the policy operates with enormous amount of detail, you know, sort of residue chemistry geek detail. So it may very well be more obvious if you sort of peeled into looking to that.

But I think the conceptual point that you and others have made is one that we can take back and take a good hard self examination.

The first point you made this issue of whether (tape goes out) environmental or other (tape goes out) where food is grown in determining whether we will allow the residue of the pesticide on our food.

I'll repeat my invitation to Shelley that if you have thoughts about either what legal rationale or what analytical approach would position us to take that into account, I think we'd be receptive to hearing about it.

MS. DAVIS: I think you get into international trade agreements when you're talking about that, and for instance, Europeans are talking seriously about restricting imports of U.S. Agriculture products that have been genetically manufactured, genetically altered. So it's not precisely a one-side debate.

MS. MULKEY: But presumably they are reacting to what the food is rather than how it is --

MS. DAVIS: I see your point. I do see your point.

MS. MULKEY: That's where the difficulty is. I think there is a lot of empathy in a lot of quarters for the basic point you're making. Dan, and maybe this will be the last word. Would you put us back on time, I think.

MR. KUNKEL: Maybe not, because unfortunately I'm one of the people who in 1996 or '97 when this thing was presented to the Science Advisory Panel actually pulled it off the web and read it, because we've had instances in Florida, because we do compete directly with commodities that have been on receiving end of import tolerances for the same commodities that we grow in Florida in direct competition to our production, and we looked at it with great interest.

And my question goes to how much has it changed from the 1997 draft that was presented to the SAP for what's coming out now relative to the detail and the discussion that's there. That's the first question.

MS. DAVIS: With regard to the number of field trials required, there has been no change. Mainly the changes have been with regard to better explaining the policy, but as far as number and location of field trials and how we do that, there has been no change.

MR. KUNKEL: Okay. I would recommend anybody get that document and read it and look at it, because a lot of the questions that were asked today are answered very specifically in that document, and it's not as technically complex as some of the other documents that we've been provided to try to determine what exactly they say.

But I would also suggest that there was some other issues raised in that guidance document relative to information that would be required by the person requesting the import tolerance on use information as far as percent of crop treated, total number of applications time to harvest. It's not necessarily required outside of field trial information in the U.S. right now. And my question goes to in the information that's created here, additional data, does that just specifically pertain to field trials, or is it also market share information for product in those importing countries and those kind of information that was detailed in the guidance document, are those requirements still there?

MS. MULKEY: I don't think there has been any movement away from anything that was in that version, right?

MS. DAVIS: No, no, there is not.

MR. KUNKEL: My question is do you have the authority to do that? Because that's a business relationship that's regulated in a different country that I'm not sure that --

MS. MULKEY: We have the authority if it relates to the issue before us. We wouldn't have the authority, I wouldn't think if it's just a fishing expedition. But if it relates to our ability to analyze the -- to make the FQPA safety finding.

MR. KUNKEL: Just asking the question.


MR. BENEDICT: Is an import tolerance country specific, or is it product specific, or is it both?

MS. MULKEY: It's a mix of chemical and commodity, but not country.

MR. BENEDICT: So if you ran an import tolerance for something on bananas, Ecuador or any other country producing bananas can import under that tolerance?

MS. MULKEY: That's correct.

MR. BENEDICT: So a lot of the information Dan is talking about is only germane to that country or the first -- actually it's probably the manufacturer requesting the tolerance.

MR. MCNALLY: This goes way back before FQPA, but there have been some tolerances specifically granted for fresh green tomatoes produced in Mexico. They've gotten that specific relative to tolerance, and it comes as a result not of the fact that it's not going to be registered in the U.S. It's a fact that the analysis to determine whether the tolerance could be set was complete. The other factors were not complete from an international marketing standpoint. The companies had requested the issuance of an import tolerance as part of their original packet. Now, I don't know whether they could do that now under FQPA or not, but this was prior to FQPA passage, and those kinds of things did create major issues for some of our industry in Florida.

MS. MULKEY: But Dan's answer is a good refinement. In defining the commodity, you might define it so specifically that it was associated with a given producing country. It wouldn't be about whether that country could export it, per se, but might have that effect. Dan is making a larger point, but to answer your narrow question.

All right. Well, thank you for a very rich and varied approach to these two topics. The import tolerance topic probably deserves it's own more thorough and deeper exploration. I really appreciate what Bob was able to do, which was to take us to 30,000 feet, but it inevitably leaves us with a sense of sort of discomfort about the details, and we are going to do this as a notice and comment type process. So there will be opportunities, and if you sense that there is some way this forum will continue to be engaged, you know, obviously we'll hear from you.

UNIDENTIFIED MALE SPEAKER: Could we get a copy of the proposal?

MS. MULKEY: Sure. I mean, I think we're pretty good, aren't we, about sending you guys things sort of over and above the normal? So with any luck we would have done that anyway, but we'll make it a point to try to do that.

All right. Well, next topic. All right. Bill is here. You caught me without my agenda. All right.

MR. JORDAN: Okay. This is section IV, FQPA science policies and packets that were distributed to the members of the PPDC. There is a document entitled Revised Schedule for the FQPA Science Policy Papers. And copies of that are available for the general public out on the table if you need to get them.

Let me just take a moment or two and tell you what's in the paper. You may read it at your leisure on the airplane flights or cab rides or metro rides, or whatever, when you leave here, and I'll be telling you a lot of the substance and elaborating on some points. But the first two pages are a discussion of what we have done so far, and what we're planning to do.

Some explanation for some changes in the approach both with regard to what documents we're going to make available and the schedules for issuing those documents as compared to the October framework notice that we issued last year.

And then the second two pages is a chart that shows the now 26 different papers that we are dealing with under the TRAC science policy heading and where we are. The simple color coding, the gray shading indicates the documents that have been issued to date, and the cells that are still just black letters on white background indicate the ones that are to be coming.

So you can look at this and get very specific information about when documents were issued for public comments and when we are proposing to issue the revised documents.

I want to step back before getting into the nitty gritty and details of this and talk a little bit about sort of overall where we were and where we are now. Last summer when Marcia asked me and Jeff Kempter to start working on the TRAC science policies, I heard a lot of discussion about the TRAC science policies. There were issues raised, criticisms directed at EPA. They fell into three broad categories.

One is that EPA has a bunch of critical science policy decisions that they need to make in order to implement FQPA, and frankly the agency just hasn't made those decisions, and that's a problem for implementing the mandate of the statute.

The second is well maybe EPA has made those decisions, but we'll be blessed and happy if we know what they are, because they are only apparent when documents emerge in addressing individual chemicals.

And then the third criticism or comment was well, you know, maybe, EPA, we do know what your policies are, but we just haven't had a chance, the public hasn't had a chance to comment on them and tell you where we think you're on the right track and where we think that you need to change.

That debate today isn't happening, and I think that's a reflection of the fact that we have made a lot of progress in getting out the science policy documents for public comment. As you look at the review, you'll notice that between the meeting last April of the PPDC and January when you most recently got together, we issued the first ten papers of the 19 that were identified. And then since last January we've issued six more papers including some of the ones that are involved with the most critical issues that I've heard discussed in connection with individual chemicals, the papers dealing, for example, with our approach to the 10X provision, the FQPA child protection factor.

We've also issued the paper related to the 99.9th percentile, the percentile of estimated acute dietary exposure that we are using as a starting point for our judging the acceptability of residues in food, and their acute risks.

We also issued the PDP decompositing paper, the paper that explains how we'll take data from USDA's pesticide data program and generate estimates about the levels of residues that might be found in a sample that might be consumed in a single serving.

So all in all we have covered eight out of the nine science policy areas. We have issued 14 of the 19 documents that were originally targeted to be issued. We've decided, and I'll discuss this in a little bit more detail in a minute, to merge two of the last two papers, number 18 and number 19 related to drinking water into the revised paper that we'll be issuing later this fall. So that we only have really three papers left to put out as initial documents for -- of the 19 for public comment.

It's been a real team effort. Jeff Kempter and I, who are coordinating it, feel very fortunate that a lot of people, very, very talented people in different divisions have worked hard on it. We've had folks, dozens of people, from HED and EFED, from FEAD, from Biological and Economical Analysis Division. Dr. Penny Fennel-Crisp from Marcia's staff as well as lots of people in other parts of EPA and the Food and Drug Administration, the U.S. Department of Agriculture have been engaged in the review and improvement of the papers that we've issued.

So it really represents a major effort on our part, and I think one that has really changed the kind of discussion. We aren't finished by a long shot. We still have a lot of papers left to revise and issue and show how we have responded to public comment.

But before getting into the revision piece of it, I want to tell you a little bit about what's coming. First of all, in October, you should look for the guidance on performing aggregate exposure and risk assessment. This paper will summarize how we approach the part of FQPA that directs us to add together exposure from residues in food, residues in drinking water, and residues that people might get from non-food uses of pesticides, for example, in or around residences, on golf courses, public areas, schools, offices, that sort of thing.

The last paper -- that will actually be papers number 14 and 15, we'll merge the standard operating procedure into the aggregate guidance.

And the last paper that is on our list of original 19 that we'll issue for comment is a cumulative risk assessment guidance. This one is coming out sort of in stages. The first stage of it is the part dealing with the hazard assessment, how we are deciding when chemicals that have a common mechanism of toxicity should be ranked in comparison to each other from the standpoint of their toxicity. That hazard part will be presented to the Scientific Advisory Panel this coming September, and so we'll in anticipation of that, send it out to the panel members and put it up on the web site for SAP probably toward the end of August, and then we'll do the same thing with regard to the balance of the paper, which deals with how do we accumulate the exposures from multiple chemicals. It's due to SAP for review in December, and then we'll combine those two and finish the review and put it out for public comment we project in January of next year.

UNIDENTIFIED FEMALE SPEAKER: Would you say that again about cumulative?

MR. JORDAN: Okay. Hazard part to the SAP in September, exposure part to the SAP in December, and then we publish it for public comment we predict in January.

And given that schedule, I would say that we may do some revisions, but probably what you will see going to the SAP will bear a very close resemblance to what we eventually put out for public comment. That was certainly a case with regard to 10X, and we are not anticipating doing extensive revisions between the end of December SAP meeting and then in January, although these issues are always up for further debate and consideration.

In terms of the science policies that were originally identified by track, that pretty much covers where we're going in terms of proposals, but within EPA, we've discovered that we actually, I won't say enjoy, but see great value in going through the science policy public comment process and so a number of additional papers have been identified to be put through the process. And there are several more that are coming soon.

Papers number 23 and 24, which Marcia mentioned earlier this morning relate to how to refine our anticipated residue estimates and to evaluate the impact of risk mitigation proposals. For example, somebody comes along and says, well, you know, we can make this pesticide safer if we'll just extend the preharvest interval, or we can cut the application rates and that would mean that we'd have less residue on food.

The question, of course, that we would need to answer in terms of risk assessment is well, what impact might that kind of change have, and if you're combining those two things, what impact might that have. The two papers that are scheduled to come out in August -- you should look for them early in August since they are now in the final stages of clearance and review, are our guidance on how to answer those questions.

It describes how to do field studies that will give us a quantitative basis for changing and revising our estimates of the residues that will eventually be found in food based on changes in preharvest interval or changes in application rate or frequency and will allow us to combine proposals to get really a quantitative handle on that.

The other papers that I want to mention in the additional group are number 25 and number 26, which deal with drinking water. What we had originally thought about doing was to publish first of all a paper describing in broad terms our approach to drinking water assessments, and we did that. That's paper number eight. It was issued in January of this year. We described in it a number of specific changes in improvements that we wanted to make to our estimation methodology. One of them was to add in a cropped area factor or percent area cropped. It's gone by different terms.

It reflects the fact that in our estimates of how much pesticide they move into drinking water, not all of the land around a pond or a reservoir is actually even eligible to be treated. Some of it will be not cropped. Some of it will be streets or parking lots or residential areas where pesticide isn't used. And so what we've done is to develop a methodology and collect data to reflect the fact that a portion of the basin that was contributing to the amount of pesticide residue to get in the water is cropped.

The second thing is that instead of focusing on a farm pond, the model will be used to generate estimates for a larger water body reservoir, a small drinking water reservoir, which also has the benefit of modeling something that people would actually be drinking from as opposed to a farm pond, which might or might not have that kind of use.

We took the ideas and the work that we had done to the Scientific Advisory Panel this past May, and while we've yet to receive the specific comments from the panel, the written comments, what folks said generally, not only the panel members but also the members of the public, who commented on it, was generally supportive of the approach.

So our notion is that we will take those two improvements, we'll reflect how we're dealing with them when we revise the drinking water paper in October of this year and will not go through a separate kind of public comment process on those two things. We feel like we've gotten enough out there, the comments that we received on paper number eight as well as from SAP and the public generally support going in this direction.

But as a result of those discussions, we identified two other papers related to drinking water that we think would be helpful for the public to look at. They are papers number 25 and number 26.

Number 25 talks about quantitative assessments of uses of concern for drinking water. That basically is instead of coming up with a single number for the entire United States, it represents kind of maximum reasonable estimate of what could be in drinking water. We will try to provide more information about the populations exposed and the variability across the United States.

Number 26 is one that will take into account drinking water, the impacts of drinking water treatment in terms of the potential of different treatment technologies to reduce the levels of pesticide residues that are present in raw water before they get to people when the water is actually consumed. So we'll discuss both of those in terms of public comment and then go through the revision process.

On the revision front, we have revised one paper, the paper relating to how to identify groups of pesticides that have a common mechanism, and we are moving ahead to revise a number of the documents that have already undergone public comment. The schedules for getting our revisions out are longer, frankly, than we had estimated when we put out our initial October framework notice, and that reflects a variety of different things.

First of all, we were, I think, overly optimistic in terms of how long it would take us to review and prepare responses and revise documents, especially since we've gotten a lot of very thoughtful comments. In some cases many hundreds of pages from a number of different organizations, and we are appreciative of the thoughtfulness that's gone into it, and the care with which you have dissected every syllable of some of the papers and offered your own alternative text. In some cases I might point out longer than our text.

Secondly, we have gotten a lot of -- we've gotten a lot of value from the Scientific Advisory Panel. And so we are going to use them, continue to use them to deal with public comments and to deal with developing documents as well, and the SAP reviews, while they do extend the time period, we think are making it possible for us to come up with better results.

And then finally, our schedules included getting everything finished by our science groups and then through internal agency reviews in approximately -- the internal agency reviews in approximately three to four weeks. Because of the interest that some of these papers have generated, folks have taken longer to look at it. So we're now allowing a bit more time for the internal interagency review process. Our colleagues at USDA, in particular, provide a lot of very valuable comment and bring their expertise and resource to bear on it.

With those sort of general ideas in mind, we are anticipating in the near term to have another five papers finished in the revised form in addition to the five that I already mentioned that we will be putting out for public comment.

The first one to come up is the threshold of regulation document. The policy there should be out in August. The residential standard operating procedures and our explanation of how we approach residential exposure assessments is scheduled to be discussed at the Scientific Advisory Panel in September, and then we will revise it after we've heard from the Scientific Advisory Panel assuming that they endorse our approaches, we are targeting December to issue that collection of documents. As I discussed earlier, we've got the drinking water paper being revised and issued in October of this year. We are also scheduled to get out the Cholinesterase Inhibition policy in October, and finally, although I would have liked to get the 99.9 paper out in 9/99 (just a little quirk there) it's actually going to take us a little bit longer, but we're targeting to get that one out in December of this year.

So we're going to be busy, and we anticipate that you'll be busy as well. That's what I have --

MS. MULKEY: Well, we had anticipated this as primarily an update, but if there are some specific issues, we have a few minutes. Beth?

MS. MarshallL: When you're talking about analyzing drinking water, I would urge you not to neglect the possibilities of ground water. I know surface run off is certainly a big part of the problem, but atrazine, for instance, is found pretty broadly in ground water.

MS. MULKEY: We do.

MR. JORDAN: We do.

MS. MULKEY: We didn't mean to leave that out. We've struggled more with methodologies on surface water, but we are including it. Steve?

MR. BALLING: I understand that since this is guidance, this is not formal rule making and therefore it should be fairly easy to make any -- that these documents then are dynamic that there is lots of opportunity for continuing change and continuing dialogue on these, because my sense is that for many of these we're very early in the science of this, and far more will be learned as we progress, and that there will be lots of opportunities for continuing to rethink some of the decisions made. I guess that's really a comment more than a question.

MS. MULKEY: We've said something very close to that. All right. Very good. Well, Jim wants to chat with us a little bit, and he can do so and not interrupt our time table. How about that?

MR. AIDALA: Basically it's very simple. As I believe Marcia said at the beginning of this meeting both Steve and Susan are out unfortunately because of ill parents, critically ill parents, no less, and so I've been covering in addition to my usual tasks, two other tasks. And I'm called away to a meeting at the White House at 5:00. So I will not be with you for the rest of the afternoon. That's basically all I'm saying and make my apologies in advance.

I will be with you in the morning, and also in terms of whenever my official opening remarks will be you're not only welcome since you've been here for five hours, that's a little stale, but also just thank you for taking your time for coming here, and this is a busy time for us all, and I do appreciate everyone taking time out from their schedules to come, and you don't need to listen to me any more, because I'm the only thing standing between you and your afternoon break.

MS. MULKEY: Thank you. Well, let's do take our break, but let's do reconvene at exactly 2:50, because there --

(End of tape.)

(Whereupon, a short recess was taken.)

MS. MULKEY: -- it's really by dint of the way we had to schedule it also primarily an informational session. I regret that every time we have an informational session that we don't leave getting something from you. I feel like there is some loss to us, but we do need to balance your needs as well as ours to have information flowing the other direction as well.

This next group is a group of work groups, which are work groups for the PPDC. Now, the route by which they became work groups for the PPDC is variable. The Rodenticides Work Group, for example, is a work group which arose out of one of our REDs, and quite frankly it was simply our need to have a forum to engage stakeholders that led us to latch this work group onto the PPDC. And I don't think it would be fair to charge any of you, let alone the collective of you, with leading us into this work group, but it is your work group. That is to say, we will report to you. That's the rules of the game regarding advisory committees. And so it seemed appropriate to let you know what we've done with this child we adopted for you so we have report from them.

The Inerts Disclosure Work Group, by contrast, is definitely your natural born. That arose out of some creative energy within this group and we'll give -- that's basically a neonate right now, and we'll give you a little report on how that's going.

I think I'm going to abandon this metaphor as soon as I say that the Ecological Standards Work Group is a teenager that needs to leave the nest, and we haven't really done what we needed to do to bring it back to you, and I'm not sure we even accomplished that today, but at least we could try to get us into a place where we can move forward on that. Leaving the next is not easy. That's the stage in life I am.

And the other activities is the abandoned -- I better abandon the metaphor now, it's those who have been so neglected that we probably should go to jail. Those are work groups that are nominally work groups that hold over from at least two-plus years ago, and we need to decide whether we really want to continue them or whether they are really history, and we need to do different business or just whether we've got it about right.

So with that keying up of the work groups report, Michael McDavit, also from our Special Review and Reregistration Division, right?

MR. MCDAVIT: Uh-huh.

MS. MULKEY: Boy, I'll tell you, that division is really shining today. Are you our sort of lead person on the Rodenticides Work Group?

MR. MCDAVIT: Sort of kind of, yes.

MS. MULKEY: And you're scheduled to do this jointly with Bob. I don't know if Bob wants to be a copresenter or just check to make sure we say everything right.

MR. MCDAVIT: He's just to check me at the end. That's right.

Lois was on the agenda for speaking today, but she wasn't able to attend this afternoon. So I'm covering for her, but I might add that I'm on this work group. I'm one of the members, the EPA members. And so I can speak to the process and the progress made to date. I think you may recall as well that I addressed you in January when we were just getting moving on this thing and solicited your input for additional membership. So we've had one intro meeting on this, but let me try to bring us up to speed to where we stand today.

In short, according to all accounts that I've come across and including those who are participating, the deliberations of this work group have gone very well, and are still proceeding, and we're very pleased with the progress that we've made.

The agency is driven to facilitate and open a constructive forum for discussing the issue of rodenticide safety, and it somehow seems fitting that we're sitting in the Jefferson room when we talk about any kind of participatory government, I might add.

As you may recall, we really got moving on this last winter, and the idea was to help the agency explore potential options for mitigating the risk of accidental ingestion of rodenticides by young children while recognizing at the same time the public health benefits of rodenticides.

The rodenticide cluster RED, which included the six anticoagulants widely used today and the zinc phosphide RED both concluded that there was a potential problem with the use of such products in and around the home. The REDs specifically cited a seemingly high number of exposure incidents involving the ingestion of anticoagulant rodenticides by young children. This conclusion was based on incident data compiled by the American Association of Poison Control Centers.

The REDs also identified a two-step process for further vetting this problem and mitigating the concern. The second step or phase of this two-step was the establishment of a stakeholder process, a work group. And so to achieve that, and we decided to explore the use of this committee, as you may recall. We approached you, I think it was in the fall originally as the vehicle for the stakeholder outreach, and asked you also to serve on the -- (inaudible) -- at least solicited interest from amongst the members of the PPDC

Bob Rosenberg agreed to serve on the group and has been an active member since we convened the work group. Other PPDC members, many regretfully declined to directly participate, but many suggested alternative members, which we pursued and, indeed, got some public interest groups and some others on the work group that otherwise we would have probably had more difficulty finding. So I appreciate that help in getting membership.

Before I move along, I want to mention, too, there is a number of the work group members here besides Bob and myself. There is also Eileen Moyer, if you could stand, perhaps from Reckitt and Colman. There is Gerry Miller from the CDFA. John Impson from USDA. And if I missed anybody, I apologize. There are a couple of alternates as well, and there is also quite a few or at least a handful of the members of the Rodenticide Registrants Task Force, which has worked closely with the work group.

The membership on the work group, we believe is balanced and representative. There are currently 27 members. There are three EPA members on this group, Lois Rossi is the chair, Bill Jacobs of RD, our registration division, is on the group as well, and possesses a great deal of experience with the rodenticides. Other parties including state tribal and local government representatives, as well as members from industry and the medical communities are actively engaged in the process and have shown much interest since we first met in March. Other active federal actors include members from USDA, which I just mentioned, as well as CDC and the CPSC, the Consumer Product Safety Commission. Overall we're very pleased with the ensemble of players and the different perspectives we have on the group, and we're very encouraged by the level of dialogue and interaction among and between the members so far.

In keeping with your charter, we prepared a mission statement, and that mission statement should be in your materials that were handed out for this meeting. We've revised it several times as deliberations have moved forward. I might add we did that in the spirit of having a kind of a generative learning process and acknowledged that the work group needs to have a vision, and it needs to bend with the wind as we learned more along the way. So it was revised. It didn't change substantially in the end, I think, but it was a useful exercise.

Even though that we're not required to have public meetings, all of the meetings to date have been open like this type of setting, and we've allowed and taken public comments. In fact, the last two meetings we've allowed public comments at two different periods during the day just to keep the communication channels open, and that was at the request of some of the participants as well.

We've held three formal meetings to date, and we also held a short conference call once. The first meeting was in March, and it was here in Crystal City. The second was a two-day informational type meeting where in the first meeting we realized that we all needed to learn a little bit more about the subject at hand. So we more or less educated ourselves at that second meeting. It was two days long, and that was in the Balston area just up the road in Arlington, and the third meeting was held a week ago today in this very room. And that third meeting I'll speak about in a second. Like most proceedings of this type had its ups and down, but in the end we were very pleased with what came out at the end of the day.

As I mentioned a second ago, the second meeting was an informational one, and the way we designed it was the first day was kind of framing the issue or framing the problem, and the second day or the second session was starting to explore potential solutions to the problem. And the meeting we had a week ago was really an extension of so what do we do from here, where do we go, what are the policy options, what are the -- what is the correct step forward for the agency.

I'd like to kind of wrap up with just a couple of more thoughts. Kind of in the spirit of participatory government or this kind of public outreach, we learned a lot as a group about rodenticides, about rodent control. We learned a lot about human incident data, and continue to learn it's weaknesses and its strengths, and we learned a bit about each other. At least processes, as you know, are interesting when you spend time with colleagues from different sides of the fence and different value sets and different perspectives. It makes for interesting personal experience as well. And we even took an outing down to the district with our district representative Mark Greenleaf, and he took us in a neighborhood where there was some serious rodent infestation and showed us how to know your rodent markings and whatnot, and we, of course, did it on one of these sweltering June days where we're having the heat wave, and besides the rodent markings, the heat about killed us, but we got a little closer in any event. But it was truly a learning experience, and the group has made efforts to cross those bridges.

So I'm happy to report today that we've prepared an initial recommendation for your consideration. And in your packet there is a one-pager simple recommendation one area where we think we've reached fairly broad agreement on in the group, and while you're looking for that, what we're looking for is your endorsement of this recommendation.

And in a nutshell, what we're recommending is that the registrant community has agreed to do mockups of new labeling for rodenticide products, and then provide those in about a month for us to review, and then we're going to share that with the work group and move on.

We're trying to adopt some of the lessons learned by the consumer labeling initiative, which in a nutshell is that pesticide labels can often be better written, better organized, certainly written for the audience. The audience at hand here is really the consumer. It's the homeowner, the person who buys rodenticide, because they have a mouse or rat problem in their home, and try to improve that label so that we can preclude at least placement problems and other easy to preclude issues that a better label would bring about.

So we're asking you for your endorsement of that, and I think it's a fair statement to say that clear and plain language labeling will go a long way in helping the care giver or the parents understand the criticality of keeping such pesticides out of the reach of children. Your endorsement of this recommendation would serve as an opportunity to pilot the wisdom garnered by the ongoing consumer label initiative effort.

If I may just move along and depending on how the group wants to work with that recommendation, I'll just finish up my remarks. We're moving ahead on several other fronts. As I mentioned a few minutes ago, the work group will be meeting again in October. Maybe I didn't mention that. We're going to meet again in October, and Lois has asked the members to come prepared to analyze and kind of finish the work of the group to look at all the other options we haven't quite finished vetting and evaluating for how to reduce accidental exposures to children.

For example, there was a great deal of interest in outreach and education pretty much across the work group, but I think we also recognize the traditional outreach methods that may not be the way to go. Instead there is some movement to look into creative ways to communicating with the consumer at the point of sale. And so to further that discussion Labelle Hicks from the state of Maine, who is serving as the SFIREG member on the work group, plans to raise this matter, just float it with the SFIREGs pesticide operation and management working committee at its next meeting in October. So the point I'm trying to make is simply that we're trying to look at nontraditional ideas of communication outreach. We're trying to go beyond the normal envelope here, but we're not finished with that issue. We're still discussing it.

Lois also offered for this office, my office, to redraft the regulatory position that had been written in the cluster RED, and to vet that redraft with the work group prior to the next meeting. Again, the idea here was to address a number of interrelated issues with the hope of clarifying areas where the agency still needed stakeholder input from those areas outside the scope of the work group, because as you'll see in that mission statement, we're trying to keep the work group focused strictly on the issue of accidental ingestions, accidental exposures to children, and there is a number of interrelated issues. Unfortunately a lot of these things, and we're just trying to make it clear which areas the agency will basically decide on their own, and which areas that are in the purview of the work group. We're trying to focus the main effort of the work group on those issues squarely within their mission.

So that pretty much wraps up my thoughts. I look forward to addressing you the next time you meet, and hopefully we'll be able to report out on the final recommendations of the work group, and Bob Rosenberg, maybe you've got something to add, I don't know if you'd like to.

MR. ROSENBERG: You know, I really don't. I think the only thing I would say is this, I think, Mike, you captured the thing just about exactly right. I think the members of the work group would probably if they were all sitting here would say the same thing and that was to compliment you and Lois and the other agency staff that worked on the process. I think there is probably still some areas of disagreement. I think we probably could dispute the extent to which there is a problem.

Not withstanding the areas of disagreement, I think the most notable accomplishment was we actually had an advisory committee or something like an advisory committee that sort of reached a consensus, and after years of coming to these kind of meetings where that doesn't normally happen, it was very refreshing, and I think we're going to get this thing done, and again, the agency staff has done a real good job of facilitating that.

MS. MULKEY: In helping this group think about this recommendation, one contribution I think I could make is that the consumer label initiative itself is a fairly extensive and comprehensive set of recommendations, not all of which EPA has adopted in that context. And so the way this has been posed to you which is to, in effect, endorse that, may not be necessarily what the work group needed or wanted from you, and being asked to do that, undoubtedly might create in your mind a need to understand all that.

So I think the question that this group might want to pose back to the work group is are you basically asking us to endorse a focus on the labeling with an eye toward plain English and enhanced understanding, and that might be a little different question the way this is posed, which is an adoption of the principles and the different exercise, which would itself maybe require a lot of background for you and might have some elements that you'd want to distinguish. So we'll try to get the other reports in. I think it would be great if the work group could get some feedback from you on this concept.


MS. MULKEY: Sure. I think we could have a shortened version that doesn't -- go ahead.

UNIDENTIFIED MALE SPEAKER: I was going to ask some of the same questions that you just kind of talked around just from a process issue of exactly what we're being asked to do. The recommendations appear to be fine to me as far as they go from what's there.

As an endorsement of this group, though, I think and this is just personal opinion and take it for what it's worth, a lot of this is work that still needs to be done. I would endorse recommending that they go ahead and do what's there. If there is going to be some kind of formal statement on how this process works relative to other issues to come before this group, which I think is a broader question than just working on this work group. Maybe we need to wait until we get the final documents to look at to come up with some kind of final endorsement of the whole program, but if we need a recommendation to endorse what they put on paper here in front of us, I would support that recommendation and make it in whatever form or method that needs to be done.


MR. McCORMICK: I had some kind of content questions, is that okay, as opposed to process?


MR. McCORMICK: Mike, when you were talking about the AAPCC data, I was curious how much learning, because of the folks that were in your work group, to what extent did you learn more in depth besides maybe the numbers of incidents that AAPCC issues. Did you guys examine more like behavioral issues, like I think you referred to product placement as a problem that labeling could help resolve. I'm just wondering how much you got into the behavior that causes the incident. Did you have any learnings around that?

MR. MCDAVIT: Unfortunately I don't think that level of information is available to get down into that detail.

MR. McCORMICK: Not even from the registrants, participants.

MR. MCDAVIT: No, but I was going to mention what we did do is that in that one session we had a member on the work group, Roseann Soloway of the Poison Control Center, and she described what they do when they get a call from a consumer that says their child has consumed a pesticide, and she basically walked us through what happens.

And then we had Dr. Wright, a pediatrician here from Washington, describe how he would treat such a call if there was referral made to him. And so we got into the kind of the logic of what happens when -- where do the numbers come from, but it's hard to go back further than into the behavior, because the data doesn't exist right now from what we gathered.

UNIDENTIFIED MALE SPEAKER: We could maybe talk about that later, but the conclusion of the work group regardless of the information gathered was that a labeling simplification is going to help mitigate the problem.

MR. MCDAVIT: We think it will contribute to mitigating the problem. We think it's kind of low hanging fruit. There is a general view that many of these labels need to be improved, and in the spirit of this process as well as general label improvement, it seemed like an opportune time.

UNIDENTIFIED MALE SPEAKER: I'm also involved in CLI. There is a Read the Label First campaign that they are trying to put together for next year, and I don't know how much this point of sale effort that you're trying to do -- it seems like it might be useful for the working group to at least connect with CLI about the activities so the people aren't doubling up on efforts.

MR. MCDAVIT: I wanted to mention, too, in this same informational session, we had someone from the agency come and speak to us about CLI. That was part of our education. So I would agree.

MS. MULKEY: It goes beyond that, and I think it's a good one. If we're going to invest heavily in a Read the Label First campaign, it may make sense to have part of that investment focus on the rodenticides.


UNIDENTIFIED MALE SPEAKER: I have one last question that's a little different. In the REDs I think there is a mention of the use of a bittering agent as a mitigating agent. Did you guys explore that at all within the work group and where does that stand?

MR. MCDAVIT: Yes, at this informational meeting we had a speaker address that and just to be fair to the process, it wasn't a good news story. There was basically some question of whether efficacy would be compromised and that maybe it wasn't the ideal solution, but we're still vetting that. But it looks like in regarding the dye issue, that also is kind of loss favor. I think we're standing now on ground that looks like we'll be deferring that if not eliminating that.

UNIDENTIFIED MALE SPEAKER: Just a comment from the cockroach side of the business, where we do use beatrix in a gel that there was a fine line between what's, you know, bate acceptance for the pest and, you know, rejection by a human. So it is a difficult thing to determine, and often times with two species like rats and humans, it could be that they both reject bittering agent. So I'm not surprised at that. Thanks.

MS. MULKEY: It's very heartening to see this degree of interest in this topic, but we'll have to sacrifice our other reports a little bit if we pursue it much. Let's pursue it a little bit, you know, knowing that, let's call on folks with an idea. Phil.

MR. BENEDICT: I almost brought this up this morning. Anne talked about the field data plan as a way to check on registrations, and I think the field data plan is part of that, but I think it goes to this too, and I really do think that labeling is real important. Some companies in my opinion, I've been doing pesticide regulation for 25 years. Some companies do a good job labeling products, and you don't seem to see problems. Other companies don't do so good, but I honestly believe one of the basic problems we have is once the agency registers a product, it's really difficult if there are adverse affects to get a simple label change made it appears to me sometimes. So I'm glad to see that label changing is part of this.

I think the agency, though, if we're going to do a better job with QAQC needs to simplify the labeling process to deal with labels that get out that don't do quite what they need to do, and I think this is some of what we're dealing with here.

MS. MULKEY: That's a topic we could spend a multi-day meeting on, isn't it. Jacqueline.

MS. HAMILTON: Just a quick comment. You said that the data don't really exist, Michael, to get a handle on precisely the behaviors on the part of the kids that are contributing to exposures, and is none of your recommendations are having to do with trying to get that data?

MR. MCDAVIT: I would say that that's probably something that's going to come out of the next meeting. We haven't really fully discussed that. It's been a common threat throughout that we need better information, and some parties, of course, feel the need more information on X and another part thinks we need more information on Y, but the point I was really trying to make is within the data base of the American Association of Poison Control Centers, they don't have that level of detail. So it doesn't exist within their data base.

MS. HAMILTON: Yeah, and is it not possible to make a recommendation that you try. I mean, I realize that they are under funded and over burdened, but, you know, try to craft one question that they need to ask or something that would try and get at some of that.

MR. MCDAVIT: Certainly, and CDC has even floated the idea that maybe they could do some research in partnership with us.

MS. HAMILTON: Okay. That was just my quick question.

MS. MULKEY: And Shelley.

MS. DAVIS: I just have one quick comment. On the label change thing, which I'm sure is a good idea, when a product has already been out there, and you're changing the label, I think it's really important to have something that says new and important information, in some way alerting people that this is not same old, same old. Because I don't think people do routinely read the label of something they've ever used before, and thus for them, you would be lost.

MS. MULKEY: That's a helpful insight. At the risk of seeming to jam something through the group, let me suggest a process here. What this work group really wants is to advise EPA to go work on these labels now, I think, if I heard it right, and they want their advice to come through you, because that's the rules of the game. So if you let me suggest that if it's interpreted with that kind of lack of specificity, so that you're not endorsing the CLI principles directly, but that basically it becomes your advice to tell the agency to go ahead and go working on these labels while you're figuring other things out, and if we can proceed by exception so that if I don't hear an objection to that being your advice, we'll assume it is, then we maybe could have checked that box. Going once, going twice.

UNIDENTIFIED MALE SPEAKER: What are we either agreeing or not agreeing to?

MS. MULKEY: In very simple terms that the work group's recommendation becomes your recommendation, not as worded here, more generally, agency, go work on improving these rodenticide labels, and don't wait for us to get the rest of our work group work done.


UNIDENTIFIED MALE SPEAKER: I thought the idea was not to say anything.

MS. MULKEY: All right. Thank you very much. All right. I think we tried to meet the needs of the work group. We look forward to a more comprehensive set of recommendations as you mature. Very good.

Well, I think we're ready to shift gears now to the inerts. You all missed my comprehensive and elaborate metaphor in which you're described as a neonative work group.

MR. JONES: We were on a conference call with some stage peers of Phils talking about developing a process to allow us to more quickly respond to label problems that they identify for us. So actually I think it was probably a worthwhile missed opportunity for us to have heard.

MS. MULKEY: We all agree that that's a topic worthy of more of our time.

UNIDENTIFIED FEMALE SPEAKER: Do we have a handout on inerts?

MS. LINDSAY: No, other than I think, although I was just searching through my package and I didn't find it, but I thought Margie gave you the Federal Register notice where we were soliciting nominations. That's the only handout this time, and that's because Jim and I think we have just a very short update for you as to where we were.

You'll remember in January we actually spent quite a bit of time, Carrie Leifer and Cameo Smoot gave joint presentations about our whole inerts policy program, accomplishments, problems, opportunities and everything. And there was actually very good discussion as far as I'm concerned from this group on the array of inerts or other ingredient. I have to train myself to say this, other ingredient issues.

One of the specific things that came from this group was a recommendation to consider setting up a work group to focus on inerts disclosure issues. And you'll know because Marcia wrote you a letter a couple of months ago, we did indeed decide to form a work group of the PPDC to focus on inerts, disclosure, or other ingredient disclosure issues.

Following the rules for doing this, we issued a notice in June, June 16th describing the mission of this group, which is really to look at current agency policy and process for disseminating inert ingredient or other ingredient information to the public, look at the processes that we used to protect CBI, have sort of open discussions on principles of disclosure or right to know, and principles of CBI protection, and then to examine options for new ways to provide further information to the public on other ingredients used in pesticide products. So that's kind of the outlines of the mission for the work group.

There are a lot of other issues related to other ingredients, and this work group at this point in time is not going to be asked to address anything but these sort of disclosure "right to know" set of issues, and all these other issues will be dealt with otherwise, like Jim's review status and any issues he's got there are not part of this group's submission.

The actual nomination period for membership closes this evening at 5:00. So if any of you haven't made your nominations, you still have a chance to get them to Margie by 5:00 today. And I do understand from her that we have actually quite a stack right now from a wide array of people. So it looks like it's going to be a popular work group.

We also have at least one other submission, which is not so much a nomination of someone to be a member of the work group, but rather raising a particular way in which disclosure can be a problem with regard to other ingredients, and this has to do with a case of alleged or maybe it actually has been found to be misuse, I'm not sure, which resulted in homeowner exposure to not only the active ingredient but to the other ingredients in the product. And for the homeowner, there is very serious concern that the exposure to the other ingredients is at the heart of the problems that he and his family are experiencing. So basically he's written to make sure that the agency will share this kind of information with the work group that we'll be establishing through the PPDC, and that those kinds of issues get considered as we look at what can be done with increasing disclosure.

So I thought there would be interest in the work group, but I guess I'm impressed that there is even more interest from more quarters than I had anticipated. Pete Caulkins in Registration Division will actually be coleading this group along with Bruce Sidwell, who is my Policy Branch Chief in Field and External Affairs Division.

Based on the internal planning, we think that the very first time we could probably actually have an initial meeting of the work group would be either late September or early October, and that's just allowing time for us to sift through the nominations that we've gotten, make some decisions about who should really be on the work group, put together a good working agenda for the first meeting, and get things up and running.

Today besides finding out what your other questions or thoughts in general might be, what I think would be really helpful for Jim and me and Bruce is to hear any advice you've got about the actual selection from all the nominations. Part of me wants to say let's keep the group small enough so we can actually do business, because I remember from the labeling work group we had, we had a very large work group focused on a very small document, and at some point it became very hard to do anything, or at least that's how I remember it.

Another part of me, though, I know we have to make sure that we really do get an array, the right array of people on the group, and there are a lot of different perspectives and vantage points. The other aspect that you might want to think about a little bit, a number of you, who are actually members of the full PPDC, either have been nominated for the work group or at least in the agency's current thinking, it might be relevant to ask you to be on the work group as well as on the full PPDC. And so that goes to some questions about what kind of reporting relationship you would like this work group to have to you, the full committee.

We can have more of you on the work group, which means then that a sizable proportion of you will just know what we're doing, or we can limit it to as few as one from the full group and have some very different people on the work group and have a different kind of reporting relationship, but I hope based on the experience with rodenticides that you figured out these procedural issues.

And so when we come back with some recommendation for you to deal with, you'll get the procedural relationship and be able to make good decisions on what's presented to you. But if you've got thoughts about really how we should go about sifting amongst the nominations, size of the group, should we have kind of a second tier outside the core group, there are a bunch of different ways you could do it.

Jim, do you want to add anything?

MS. MULKEY: Do you want to spend a few minutes with your reactions to what you've heard? Okay. Shelton?

MR. SHELTON: Thank you. I just want to, I think, repeat what you said earlier, and that is the issue here is that I see commonly is acute illness that develops in formulations that I don't think have anything to do with the active ingredient, and the result of the inert ingredients and the positions have no way either of finding out, in fact, they don't even understand this issue at all. So I hope that someone in this working group really gets that.

MS. LINDSAY: I'm hoping at the first meeting of the work group that one of the important things we can do is just a collective building, agenda building of what are all of the issues that we maybe want to take a look at so that, you know, coming from your perspective, that would be a very important set of issues to look at. If you're a producer of an inert ingredient, you may have some other issues so that we build a detailed agenda to start with.

MS. MULKEY: Sheldon, do you have any thoughts about what kind of person to look for to bring that perspective to the table?

MR. SHELDON: I think, yes, I would think that somebody in occupational medicine, who has a strong interest in solvents, as an example. Somebody who has got an interest in organic solvents certainly ought to be on that work group, and then I think you might try to find somebody in poison centers or somebody who handles the calls, you know, that come in because of these type of chemicals would be the second type of person.

MS. MULKEY: Warren?

MR. STICKLE: I know we have talked a little bit about this in January and in subsequent meetings since January. But I think if we're putting together an inert disclosure group to deal with that issue, I think it's really important that some of the scientific and technical expertise that exists with a couple of the inert manufacturers, people who know exactly what we're talking about as far as the inerts, the formulation of inerts, and how that is actually put together would make an important contribution to such a group. And I know we've talked about these concepts and these ideas before, but I just wanted to raise that again at this point in time.

MS. MULKEY: Do you know if some specific individuals have been identified through our nomination process?

MR. STICKLE: I know that we've made some recommendations along those lines.

MS. MULKEY: Very good. Great. It sounds like that's the feedback available for today. Does anybody want to speak to this issue of whether, to put a little sharper point on what Anne said, rather than having a lot of you serve, we could have this one tethered a little more closely to you than we have had these others. So there is not only just reporting at this meeting, but some sharing of documents and some opportunity for you to follow it more closely without being a member. If there was a general sense of that, that would really help us in selecting the membership.

In other words, if you would like to trade off a lot of your own direct involvement for a little more frequent and intense interaction, and there was some broad view toward that effect, you know, we could go that direction in terms of selection, and vice-versa. If you really don't think that's very workable, and you think that the people really care in this group even if there are five of them or ten of them or whatever to be direct players. Any thoughts on that either direction? I guess not.

Well, this next one, of course, we've run out of time for. We have done this to this topic three times. We just can't do it again. What we do need to do, however, in addition to having the very brief report that is scheduled today is we need to find a way to get past one more brief update on this ecological eco frame or whatever we want to call it work group and move it to another place vis-a-vis this group. So I suggest we listen to this brief report, and we are borrowing time from an important next session, but we've just got to do it, and then we'll see where we want to go from there.

MS. KEEHNER: Okay. At this time yesterday I was having a root canal. So my goal today is to have a better time than I had yesterday, and to have my mouth shut, close my mouth within ten minutes. What I thought I'd do is very quickly provide the PPDC as a group with some feedback from OPP on the five recommendations that the ecological standards work group had made to OPP about improvements to the ecological risk assessment, risk management processes, tools, and methods, how we basically approach ecological risk assessment and risk management. Kathleen Knox and I have been -- were the chairs of the eco standards work group, and that's why we're here again today.

Very, very quickly, the eco standards program work group was set up in May of '97 to basically advise the PPDC on areas of improvement in the ecological risk assessment process and the risk management process, methods, tools, the idea was for the work group to take a look at what we do and how we do it and to make some recommendations for improvements to that process.

It was very clear early on that the work group itself needed to become better educated as to how the agency does ecological risk assessment and what the methods and tools and approaches were and what kinds of decisions were made. So we spent a fair amount of time going through case studies and bringing everyone up to speed on what we do and how we do it. In May of '98 the work group sent a report to the full PPDC, and we did a presentation at that time as well.

In January of '99 the PPDC talked about a process for bringing this work group report to some kind of a closure, and in February Margie Fehrenbach as the DFO sent out to all the PPDC members a formal report with recommendations and sought either concurrence or nonconcurrence from all the PPDC members on the recommendations that were contained in the report. I believe the date for concurrence or nonconcurrence was February 25th.

As a result of that process, we received concurrence from three members at PPDC. And so I'll acknowledge those three today, Beth Marshall, Ken Rosenbaum, and Dr. Wagner actually did respond to the request for concurrence or nonconcurrence.

So what's happened since February has been we've taken a look at the recommendations. We've considered the recommendations, and what I'd like to do is very quickly give you some indication of where we and OPP are with regard to the recommendations that were made.

The first two recommendations, it's kind of interesting, because those first two are about issues of OPP being more open, transparent, clear and communicative with regard to what it's doing, how it's doing in its assessments, and to making that more accessible to the public. We, as an office, do agree that there are great benefits associated with -- we believe there are great benefits associated with being more open, transparent, clear, articulating better what we're doing and how we're doing on an individual case basis.

The experience of the past several months with the organophosphates is a good sort of indication of what can be done to further the public disclosure process, the technical briefings that are being held, the placement of risk assessments on the internet, and that entire sort of public accessibility initiative with regard to organophosphates is a good example of following through even though it came through a different path with those basic recommendations to make things more accessible and to make things more readable and clear to the public.

Of course doing that, going through that type of a process has some cost associated with it, and we are going to be evaluating what the costs and benefits are of going through that kind of public, that open disclosure process associated with organophosphates, and we're going to have to make a decision as a program, as an office, about institutionalizing those kinds of changes for other than the organophosphate insecticides.

The other two recommendations dealt with areas in our ecological risk assessment that the work group felt needed more emphasis, specifically a need to do more in terms of characterizing and evaluating ecosystem level impacts, impacts on diversity, impacts on predator/prey relations, those kinds of things, and also a desire to have us address more impacts, economic impacts and other impacts on fisheries, and things like impacts on beneficial insects as part of our assessment process. And we do agree as an office and principle that that is something that needs to be done --

(End of tape.)

MS. KEEHNER: -- needed in order to fully understand those kinds of impacts, and that would be the beginning step in the process of modifying how we approach those areas in our assessment process.

The final recommendation was about the need for us, as an agency, to develop a better understanding of the magnitude and the severity of ecological impacts. This gets to issues of being able to provide the risk managers with a fuller understanding of what the severity and magnitude might be of ecological impacts versus doing a simple screening level kind of an assessment, and we do agree with that recommendation that we need to do more in that area, and we need to pursue that area. The ecoframe initiative was endorsed by the work group as an important process in the direction of developing those methods to provide that sense of the magnitude and severity of impacts. And we do accept the recommendation of the work group that we need to pursue partners in order to develop the necessary data methods and tools to really fully see that through implementation.

And we are, have actually, started some activities in the development of an implementation plan for ecoframe and also in much more active discussions with the Office of Research and Development with regard to their long term -- in EPA, with regard to their long term research strategies in the ecological arena. And we're playing a much more active role this past spring, and very clearly laying out the kinds of research that we see needs to be done in order to fully implement some of these recommendations that came out of the PPDC eco standards work group.

And I think I kept with my goal of keeping under 10 minutes.

MS. MULKEY: Thank you, Denise. Well, what we have here is a work group that worked a great deal. At least one member of the work group told me in some confidence that they thought the impression that it was so much of one mind may have been a little bit less than accurate, but not withstanding that, it was sort of a directional thrust that came out of the work group to this group. We've made an effort to try to check the box about whether it becomes the advice of this group.

We've now given you in very general terms today, general but straight forward, transparent sort of how we're responding to that. We can declare victory and go home on this topic. That's okay. Alternately, this group may want to tackle this topic in some new or different way either by reference to what has gone before or some other way, and I think we would welcome your feedback.

In the interest of keeping on today's schedule, unless somebody needs to ask a question of Denise and Kathleen, perhaps we can make that as part of our discussion of next steps tomorrow. I will then -- anybody want to speak to any of that? Larry?

MR. ELWORTH: Can I just raise one question? It's come up a couple of times today, and Dan tried to mention it, I think if we talk about next steps, we can do it at this meeting or at another one. The reason I don't have any hesitation at all about this rodenticide thing is we really don't have a clear way of deciding what is and isn't a recommendation. I mean, I think you did all the work you could possibly do, but did in fact, the fact that you got three concurrences on this means -- does that mean the PPDC concurred or didn't concur, and what does that concurrence mean in terms of form advice under the Federal Advisory Committee Act, things like that.

I mean, I don't want to be especially legalistic about it, but I am interested in how, for example, there is no way on God's green earth that I can read through all this stuff on the rodenticide issue. I have no doubt that good work was done by many people. However, if you ask me to endorse it as a recommendation, I feel like I have a higher level of responsibility to the material. My attention to it may not add anything, but I'd feel required, you know, to do it if somebody asked me. So if we can have some discussion?

MS. MULKEY: I think that's a healthy question, and it really goes to this whole issue of how we use work groups and what they mean. Toward that end for my part of this part of the panel, I will simply say that in case you didn't realize it, there are three or four work groups nominally still on the books, and Margie, I've gone and lost my piece of paper, I don't even think I'll try to, you know, a couple of which have sort of been superseded by track, because they were about minor uses and/or about health affects analysis, both of which sort of have been focused. One was on GPRA and how we measure our success as a program, something of great importance to us, but not active now and one was on communications, which focused on the consumer brochure, and I think probably people think it's over, because that's over at least for now.

So as part of our discussion tomorrow about next steps rather than today, fold that into your background thinking about what we want to talk about, the way we want to operate work groups, and it's clear that ten-minute updates are not the kind of nexus that's going to get us where we need to go, but it may be that it's okay for this one, and that it's okay that the two we want now to be active on are rodenticides and inerts. Okay. Thank you.

The next presentation, for those of you who are not familiar with the pesticide environmental stewardship program, you're in for a treat. And for those of you who are familiar, I hope you will help and some of you are intimately familiar with the program. If you'll help Janet, Dr. Anderson, and whoever of her colleagues are copresenting to get the message out to your peers, and then I hope this will provoke some discussion, and we'll just use the time. We'll just work a little long today if we need to be sure that whatever you want to engage in on this topic is done. We have lost 20 minutes to the original staging of this topic. Try to save a little bit of time, but this is one I think everybody wants to be sure they get the benefit of.

MS. ANDERSEN: We passed out a package so it's bright red. Some are blue. Marcia mentioned earlier that she'd like to have participation more than just talking heads, and that's indeed what I intend to do in this session. That there are four members of the pesticide environmental stewardship program who are partners and supporters. You'll find out what that means in a minute if you don't know already, on the PPDC, and I've asked each of them to participate. We've got several EPA people we call liaisons, who are also in the audience, and they will also have maybe a chance to add a word or two before there is also a discussion.

So the pesticide environmental stewardship program is one of EPA's voluntary programs. It's based on partnerships, public private partnerships, and this one has the goal of reducing the risk from the use of pesticides.

As I said, there are four members here, and I'll go around this way, and it's Steve Balling, who classifies as the supporter category. You'll get that in a minute. Dan Botts's organization, Florida Fruit and Vegetable, Bob Rosenberg, and the National Potato Council with Dave Lavway here, are all members of the stewardship program.

And as I said, there actually are some others in the audience who we will appreciate, too, if they may even have a comment here and there they may want to add, and we'll see if we can slip it in. I want to give just a background overview of what this program is all about and talk a little bit about some of the things I think are going on in the program, and then ask each of these partners and supporters to add a little bit to the conversation. Without directing them totally, I've given them some hints and ideas of things that they might want to cover.

Pesticide Environmental Stewardship Program, or PESP grew out of an administration initiative that it was in response to the National Academy of Sciences report on pesticides in children. There was congressional testimony a few months later where it was combined USDA, EPA, and FDA and made two commitments to Congress at that time.

The first was a 75 percent of agricultural acreage would adopt IPM by the year 2000, often called the IPM initiative. And the second was to work with commodity groups to reduce pesticide use. That was the actual language in the testimony.

The first one of these, 75 percent adoption of IPM is a USDA lead, and the EPA took the lead on working with the commodity groups. When it came back to the program, when it came back to OPP to actually do it, we put our own twist on it. We looked at it, and said it's not really use reduction that we're interested in. It's actually risk reduction, because you can reduce use and never make a difference in risk, and that was really our goal.

And second of all, we didn't want to limit it to just commodity groups. We thought there were lots of pesticide user groups, and you'll see a chance to look at that, Bob Rosenberg's group has a good example of a non-commodity group, who is really now active in the program.

So we made the program broader, and we changed the goal a little bit, and as Jim Aidala told me early on in the program, we also changed the name of the initiative, which once was called the use risk initiative, and all we just seemed to discuss was whether use reduction or risk reduction. We moved it to pesticide environment stewardship program.

We did hold a number of stakeholder meetings, where we had all those discussions, and then in November of '94 12 organizations were ready to say that they were willing to work in partnership with us, and we call this group our charter partners.

We made a communication in that time a press release, and talked about what each of these groups was interested in doing in reducing pesticide risk. All of them made a commitment to IPM or integrated pest management, and all of them did it in their own way. We believe that each partnership needs to be unique in the sense of what really works for pear growers is not going to be what works for potato growers is not going to be what works for pesticide applicators in the home environment.

Shortly after we created the program and launched it, we had a number of groups that came to us and said, well, we really think this is a great idea, but we are not pesticide users. Our partners were pesticide users or represented pesticide users. We want to participate, too. So is there a way that we can come into the program. And we created the supporter category as we said. Supporters are groups who work with pesticide users but not necessarily users themselves.

And Steve Balling is in that supporter category. Del Monte represents that. We have Gerbers, and we have General Mills and Campbells. They are all in the food processor area. But we have golf course superintendents that are partners, and we have associated them, the U.S. Golf Association. We have a number of them that where a supporter works directly with a partner.

We also have supporters, though, that have joined this program, who don't actually work directly with a PESP partner, but are working with groups that use pesticides to reduce risks, and that's quite all right. There are now about 100 organizations that are in this program. Out front there is a list of partners and supporters, and in your packages there is the same.

That list changes here and there over time, and we try to keep it updated on our web page. I want to speak just a little bit about what the role of a partner is, what the role of supporter, and the role of EPA in this program. It's really more than anything I think it's about communication, and it's about finding ways to reduce pesticide risk that we can work together to make those ways happen.

Partners are actually asked to develop a strategy. And we've changed this a little bit in the last year. We're now asking them, set your goal, talk about the activities that you're going to do to meet that goal in this particular year, what those activities will really mean in risk reduction, and how you're going to measure whether or not you are successful.

In the past we have had supporters to work with a group that's using pesticide, and then help them reduce their pesticide risk. I won't steal any thunder by telling you what Del Monte has done, but I will say that there are groups that have worked in different ways, and Campbells, who isn't here today, Campbells has worked with the processed tomato and some of the fresh tomato people, too, but especially the processed tomato people to help them reduce risks through a number of IPM activities, and that's an example of projects they are. You may hear others as people speak today.

We now are asking those supports to come in and say what is your strategic goal for this program for how you're going to participate, what activities are you intending to do, how will they help us with risk reduction and how are you going to measure them. So we've now raised the ante on our supporters.

EPA takes an active role in this, too. We have for each of these groups that are here, each one has a liaison within the Office of Pesticide Programs, and a couple have somebody who is their liaison actually in one of our regional offices, where that's more appropriate. This means that there are about 90 liaisons across the Office of Pesticide Programs. They serve in every single division. That means they do not report to me. And, in fact, they are not my -- even my Pollution Prevention staff, which is much smaller doing it.

So we have to coordinate in a very broad way in working with this all, and we train the staff in how to work with these outside groups. It's a different kind of thing than sitting and doing a review, as you might do in a typical day, but it gives them a chance to really work with people, who have to face the regulations we put in place, and it gives us often a chance to really get out into the field and see what's really going on in agriculture and non-agricultural settings.

We think that the liaisons and the communication back and forth is one of the real key to the programs that really makes it worthwhile on both of our sides, because when we have questions then about how a pesticide is used, we've already built a relationship with a particular group, and we can go and ask them questions, and we think this has been very valuable in some of our regulatory actions to get us better regulatory decisions.

Under this pesticide environmental stewardship program, we've run a few small grant programs. One of the pieces in your packages not out for everyone is the listing of the grants that we've given since we started in '95. And these are partner supporter grants just alone to partner supporters. They are for small amounts of money, and they are really aimed at helping these groups adopt safer pest management practices.

Now, it's not that we're trying to hide this from anyone of you. We want you all to go out and look at that, but I want you to go to the web site where it's all listed, which is WWW.PESP.ORG. It is run for us by the IPM Foundation, the National Foundation for IPM education. They do it under a cooperative agreement that also runs this grant program. And the reason they run our web page for us instead of us putting it on it, is that there are regulations for what EPA can actually put on the web page, and there are so many good things our partners are doing, we couldn't put those things on our web page. So the foundation helps us out by putting it out and making it a bigger -- much more information available.

So beyond the partner and supporter grants, we also have a series of regional grants. Each of our regional offices has some grants that we coordinate together for pollution prevention and especially for pesticide pollution prevention activities.

A lot of these have ended up with emphasis on IPM in the schools, and I think that's been a real asset for us in that kind of area. We also have done a few very large or large for us, anyway, grants on specific activities that we're helping to fund. One is the Wisconsin Program, with the Wisconsin Fruit and Vegetable -- sorry, Potato and Vegetable Association that you've heard about in a number of different forums probably. We have also done some cooperative work with -- through American Farm Land Trust from us and also with the Pugh Foundation in looking at helping fruit growers in the pacific northwest adopt pheromones and other kinds of technology to reduce risks.

So there is a number of those that are ongoing and also in the granting program. I have told you about the web page, which is very important to us that people really look at it for information, and the one thing you're going to start seeing on that web page if you look there today, is that we have been holding a series of regional workshops where we actually go out into the real world outside that beltway and see what and talk to our partners, see what they're doing, talk to them about their issues and trying to understand them better.

We've held them in the west and the south, and this year we held one in the northeast and one in the central part of the country. This year on November 17th, which is just about the fifth year anniversary of this program, we will also have our second national meeting here in the Washington, D.C., area and that workshop will be including all of our partners and supporters we can have come into the area with a real emphasis on them, but of course those meetings and workshops are open to the general public.

So that's my overview about the program. I'd like to if I could just start with Steve and then ask Dan to speak and then I'm going to turn back to Dave Labway and then finally end up with Bob Rosenberg, and Kevin, if you have a minute at the end, I'd like to have Kevin Sweeney speak about what it's like to be a liaison. I'm sorry, Kevin Costello speak about what it is -- too many Kevins. I'm sorry, Kevin Costello, who is a liaison to the Hood River Growers in Oregon. So Kevin, if you might come up to the table, too, and be able to speak for a couple of minutes. We'll start, though, with Steve.

MR. BALLING: Well, this is a little bit of motherhood and apple pie. It doesn't have the same pithiness that some of our other discussions had, because it really is one of those ones where I think everyone wins in this whole process.

Del Monte specifically became involved as a charter member through commodity organizations that we've worked with, California Pear Growers, and the whole pear industry in California, California Processing Tomato Growers, and California Cling Peach Growers, all of which were charter members in charter partners in PESP. And then when they created the supporter category, we were charter supporters, and you may wonder why we want to get so involved with EPA, but EPA has, as you can tell from our discussions is a pretty significant influence on our lives and our future.

One of the things that we have been discussing, Del Monte has been discussing with commodity groups for the last decade is the idea of developing transition programs, moving away from older chemicals, knowing before anyone knew FQPA was coming that FQPA was coming. We knew that this is part of the continuous improvement process in American agriculture. And the idea has always been how do you get ahead of a curve, and we've tried to do it through various mechanisms, through research programs, through funding of implementation, but one of the other ways was to partner with EPA. So that EPA was on board with the process that we were trying to move forward and, in fact, EPA could help us move that process forward.

What we're seeking is a sustainable production system over a long period of time. We want to keep continuing to produce pears and peaches and tomatoes in California. Janet mentioned that this is all about communication, and it really is. EPA -- what PESP has offered us and the commodity groups is a window into what EPA's activities are. What EPA does is they have a liaison. They keep you informed about the kinds of decisions that are being made, why decisions are being made, and you in turn as a partner or supporter have someone you can go to when you have a question, and that person will find out the answer. And we'll find out the answer.

What is really -- it's been remarkable to see the change in attitude of growers about what EPA people really are, and it's the old thing that if you sit down and have a beer with somebody, you can't hate them. And what we've had is we've been able to get the liaisons out into the field, to walk the field with the growers, and they begin to understand each other's problems and that they are real people, that it's not some organization, some giant organization that you can't interact with. And then, of course, Janet had mentioned the financial aspect to this, PESP has offered grants for risk reduction measures, and if you go through the list that she gave you, I think it totals over $1.2 million over five years that EPA has funded primarily IPM type programs, largely educational. A lot of the ones we've been involved with are demonstration blocks for tomato programs, maybe confusion efforts, pheromonal work in peaches to, again, demonstration blocks.

They funded some precision agriculture work in pesticide reduction in peanuts, electronic fruit sorting in cherries, which they are doing in Michigan, and that's something that we are very interested in internally within our own company. We haven't gone through PESP yet, but we are looking at ways of processing out contaminants so that we do less spray up front or actually at the end of a crop season.

I'm on the board of the National Foundation for IPM Education, and we are the ones that review all of the proposals that come in and in turn offer the grants and audit the programs when they are done, and it's become an incredibly strict program. It's one of the more tightly managed grant programs I've ever been around, specifically because we wanted to make sure that we felt as the foundation, the IPM foundation that our name was on the line here, and if the work wasn't being done, if quality work wasn't being done, then we would suffer as well as Janet and her group supporting.

So we have really cracked down, and the quality of the efforts is really superb, and I think a couple of them I am most excited about, one -- both of them local, I admit to us in California. One is the city of Davis has been doing work in building IPM programs and understanding of what happens in storm water systems and what goes down the drain. And so has the bay area storm water management group doing some of the same kinds of things trying to educate people about what happens when they use certain kinds of products, and how best to use those, how to use them safe and, in fact, how to offer alternatives.

And the reason I'm excited about that from the context of integrated pest management is when the public begins to better understand what IPM is, then we have an easier goal in agriculture, and this PESP program has begun to develop those kinds of educational programs, and motherhood and apple pie. Thanks.

MR. KUNKEL: Not being able to claim charter membership status, I think an explanation is a little bit due in the process. When it was first proposed and floated out there, and I think all of the rest of the groups are charter members, most of the groups that took advantage of participation were single commodity group focus organizations, either like Steve was saying pears, and peaches, and potatoes, and some of the other charter members.

Florida Fruit and Vegetable Association represents 35 different commodities at a minimum. That's not counting all the spice varieties and some of the Asian products and all the tropical fruits that are grown down in Homestead that most of us don't even know what they look like much less how to pronounce them or treat the pests on them, but we have a responsibility to our membership to represent their interest as well, and after a year of watching the process and looking at the way the program was set up and the way it was being administered and being run, we came back to the agency and said we would like to participate, how do we do it as a multi commodity organization.

And quite frankly a lot of the things that the partners were being guided into doing, we had already started to work with in our membership '87, '88, a long time before PESP was there, looking at things to minimize as much as possible those inputs that represented risks to the environment, to the workers, to the people that were actually growing the crops, and also prevented any kind of potential marketing handled down the road.

We initiated several programs of joint education with our membership on issues as far ranging as storm water run off and nutrient management and pesticide use and semi-aquatic situations to micro biological food safety, which is not directly pesticide related issue, but it's all interrelated in what we do.

We've had a program instituted since 1987, where we have been going to the R & D companies, looking down the pipeline many years prior to even hitting the numbered compound stage with glimmers in the eyes of some of these registrants identifying potential niches for things that represent significant problems for us that we feel are the at-risk compounds that have been identified for various reasons, where there is acute toxicity or worker exposure or carcinogenicity concerns or other issues trying, to identify those things that would make our memberships production the least environmentally -- (inaudible) -- as possible.

So we were already doing a lot of things that we didn't know how to put into words to be captured in the strategy to go with being a PESP partner, and I want to do a plug for the liaison committee now even though we share him with the Cranberry Institute and the New York City Board of Education. I think he did that so he gets a real diversity of input on what he's looking at or the fact that he likes to fish and he's hoping to come to the Keys and go fishing, I'm not real sure.

But if it had not been for the liaison relationship, I don't know that Florida Fruit and Vegetable Association would ever have successfully completed the strategy document in putting the program together just because of other things keep coming up in the process that moved that to a lower priority. We do have a strategy, and I think I'm correct in saying that there are some charter members who haven't met that deadline yet.

So I'm ahead of the charter members in that respect, and in fact, I have the draft of my revised strategy here to be submitted before the end of week after next. Our liaison said he couldn't retire until we got our first strategy in, and my goal now is to be sure that I lag just long enough so he misses his anniversary date so he can't retire on an annual basis until I get ready for him to retire, which is probably about 25 years from now.

But some of the things, and I was specifically asked to discuss where I see the program going especially in light of some of the major issues that are facing us out there right now through implementation of FQPA and some of the other issues. I think this is an untapped resource within the agency from a two-way communication street type basis. It can serve as an early warning system both for the agency and the commodity groups to be able to move into a process of identification of things and processes that may be at risk to allow for a less contentious or controversial transition period should one become necessary as we move through the tolerance reassessment process and the FQPA interval in concert with the minor use program and some other things. There seems to be some natural mixes in the process internally within the agency to move this process forward if the communication link can be established, and a lot of times it seems at least to me, and I'm probably more engaged than a lot of people on a lot of these issues, but some of the things that we're hearing out on the street are things that come as news to our liaison people in the agency as well, and there needs to be a much more constructive communication link established in this process.

So from that standpoint, that's probably the only negative I can say about the program and my participation in it, and that's not really a negative. It's just something we need to work on together and move forward.

MS. ANDERSEN: More organizations are not charter than they are.

MR. KUNKEL: I didn't get a pin.

UNIDENTIFIED MALE SPEAKER: My first comment would be that I think I could store potatoes in this room for ten months -- (inaudible) -- USDA color chart. Secondly, I found out last night that I needed to sit in today for Dean Zulegar, and I said, well, that's good. It gets me out of having to go over to a subcommittee mark up on crop insurance, federal crop insurance this morning. If you think some of this is complicated, try to figure out federal crop insurance. But then I found out at lunch time that I had to give a report, so I almost went to the crop insurance meeting.

Seriously, the National Potato Council as a charter member about three years ago, we decided that if we were going to be a part of PESP that we wanted a program that growers would use and that was measurable. So one of the things that we did early on was try to come up with a definition of IPM with a point system. It would be grower friendly, that a grower could sit down without any researcher or anybody else explaining to them and go through and actually rate themselves on a continuum.

That's a pretty big task to undertake, because there was a lot of different definitions of what was and what wasn't an integrated pest management practice. But Dean, who started out with the grant, actually was the one that pretty much wrote the proposal and went through a lot of different groups reviewing it, a whole bunch of extension people from across the country.

At least 10 states were involved, and we came up with a protocol that included practices like preplanting and planting and salt and water practices and insect control even to storage, harvest and storage. And this past year actually we were able to take it out. We developed a supporting document to go with the practices. We took it to different potato states during our winter potato schools. We had about 200 growers that completed it, and scored in the vicinity of 92 percent adoption on a continuum. We have put it out as an educational tool. We think it is very grower friendly. We're actually able to develop it through a grant from PESP. We've had a lot of interest in it. We've sent copies of it to Portugal and Australia, as well as a number of states, a number of different commodity groups, and if any of you are interested, we would certainly send you a copy of the protocol along with our brochure.

Our goal this year is to add another 220 additional growers to the survey in the winter potato schools, and hopefully over the course of years it will continue to be refined. Growers get, you know, points for -- they look at different things like biological, physical, mechanical, cultural, and chemical practices. From those standpoints, and they get more points, of course, for biological and chemical, but we think it's a pretty good document and, again, if you're interested, we'll get you copies of it. And I know Bob wanted all the time he could get, and so I'm going to turn it over to him.

MS. ANDERSEN: Bob, just because I did say you could have -- Kevin, where are you. If I could just have Kevin give a little perspective what it's like to be a liaison, and then we'll get --

MR. COSTELLO: Sure, no problem. This will just take a minute, really. I think that we liaisons within EPA actually garner some intangible and some very practical benefits out of being liaisons in the PESP program. I guarantee you we appreciate what was mentioned before that by going out and by meeting the various people in the grower groups, we actually obtain a face and are not just, you know, blank bureaucrats way out -- way in here. But by the same token, there are at least 90 people now within the agency who have more than just a desk bound perspective, and get to talk to and see the folks that are directly affected by the work that we do.

On top of that, it gives us a day to day perspective that as we do our work, we can't do it in a clinical way, and that the work that we do is really not just a two-way street between those of us that are reviewing what the registrants have given us and the registrants themselves. There is at least that third party that is interested in what we do.

But on the practical side as well and our day to day work, knowing the people in the PESP program can really be a benefit to us. In preparing, for instance, emergency exemption requests, oftentimes have come where what has been written for us, the use of the chemical that's being proposed, if there is somebody in the PESP program that we can just pick up the phone and call and say, this is what we understand and this is where we see the risk to be, and then get actual agronomic information, that may actually refine what we were thinking and in that way not be too heavy handed where we might have accidentally said something that wasn't exactly accurate.

By the same token something that has helped as well is getting comments in. In one case in particular I remember getting comments in that were very negative about what we did for one particular exemption and the chemical that we proposed might be a good replacement. Upon calling one of the grower groups, we got the answer, well, that's Charlie. Charlie really doesn't necessarily agree with what the rest of us say, but he does have a point, and it gave us the perspective that even sometimes when we get criticism, it isn't necessarily speaking for the whole group.

I'd say that mostly I hope that those of us that are liaisons in addition to being contacts here at EPA for our particular grower groups, that we actually may help give the same perspective to the other people throughout the divisions as Janet said. So that we can at least soften the blow of what we do by letting people understand that there could be some effect.

MS. MULKEY: Do you want to describe what your regular job is?

MR. COSTELLO: Sure. I'm a public speaker. No, I guess not. Sure. I work in the Environment Fate and Effects Division. I'm part of the group that actually Denise Keehner leads that figures the effects as best we can, assesses the risk of pesticides to be balanced against what the economists figure in the risk benefit equation. And I think that our group gets, especially gets benefit in getting the agronomic information, getting the location information and sometimes finding out just how very important certain pesticides are or are not to a certain commodity. I know that there are different shades of this kind of interaction for different groups, but for me and for the people that I work with, the direct contact that is possible with the growers has been especially useful.

MS. ANDERSEN: Great. Thanks very much. And I'm going to give Bob now his.

MR. ROSENBERG: We're not either a charter member. In fact, we're not even successfully completed a strategy yet, and I guess the price you pay for that is being last.

NPCA is a, I think, playing off of what Dan said is a very different kind of an organization than a commodity group. We've got 5,000 member companies. There are probably 5,000 different ways of doing business. Some are small companies. Some are large companies. They are spread across the United States. They are in every state in the United States. Some are urban. Some are rural. There is more in the south than in the north. Some do just residential work. Some do commercial work, like schools, hospitals, office buildings, restaurants, hotels. Some rely very heavily on termite work. Some do general household pests. Some of them do lawn care, mosquito abatement, roadside vegetation management. Lots of them are involved in post-harvest food related pest control, things like export, import, fumigations, or food processing plants, graineries, silos, mills, and things of that nature.

The most important difference, though, is they span a wide range of practices. There are -- I think the, I guess -- well, at the very low end of the folks that we represent, there are still a number of those 5,000 companies who probably do still spray baseboards on a monthly basis, and that's, you know, what folks came to expect from PCO's 20 or 30 or 40 years ago. And on another extreme we have a number of companies who provide low impact or reduced risk or in some cases nonchemical pest control services. And most everybody falls in between.

What I'd like to do is use this time to kind of talk about sort of an issue for us in our involvement in the program. Namely it's this, as Dan said about Florida Fruit and Vegetable, NPCA has for a number of years done a lot of things that we are proud of in terms of their having resulted in reduced risk. We peruse lots of training materials and technical materials. We conduct workshops and seminars, almost all of which are designed to promote IPM smarter use of products, alternative technologies. We've done a lot of that kind of stuff. The two things that we think are the salient points about our organization as it relates to this program is, I guess, number one and most importantly, we don't apply pesticides. Our members do. So our participation in this program itself does not directly result in a reduction of use or a reduction in exposure.

Secondly, there is nothing we can do to compel our membership to do anything. Even if it's a sensible thing to do. The challenge for us in this program has been this, has been how do we get 5,000 companies to modify their behavior, to adopt practices that would be reduced risk practices or to engage in more training or the kinds of practices that I think we and EPA would agree are things that are worth pursuing. What we, I think have kind of concluded and wanted to kind of talk about here today, was something like this. PCO's are typically small companies, like say some big companies, they are typically small companies. Basically PCO's respond to market incentive. They do what makes them money. If they can provide a service, which is profitable, that's what they do.

Our experience in the market place is despite what we tend to talk about in meetings like this and talk about risk reduction and IPM, what we find is the thing that actually drives the marketplace in this country, people who actually pick up the phone and call a pest control operator are one people, who are looking for something that's cheap, two they want something that's convenient. They don't want to have to go back to the house lot, you know, to work with the PCO, and three, they want something that works. If they've got a pest problem, if they've got a rat, if they got termites, they really aren't particularly interested in hearing about IPM and reduced risk. They are interested in getting rid of a termite infestation or, you know, rodent infestation or cockroach infestation. One of the least -- we've done dozens of focus groups. We've done surveys. One of the things which least motivates consumers in the pest control market is environment concerns. So our challenge is one, to try to change that marketplace, and two, to try to provide incentives to our members to get them to modify their behavior.

So what we had in mind was something like this, and I won't go on much longer. But what we had in mind was something like an energy star program, where NPCA working with Janet's group and by the way this applies maybe to PCO's, maybe it applies to lawn care operators, maybe it applies to tree care guys. Maybe it doesn't apply to --

(End of tape.)

MR. ROSENBERG: -- to do reduced risk things, but I don't think you all probably want to do that. But if we came up with a logo that was an identifiable logo that was able to convey the message that that company has, you know, has adopted certain practices, which are practices that we agree are good practices, then they'd be permitted to in their yellow pages advertising or in the literature that they distribute, be able to say that they are, you know, pesticide environmental stewardship partner in EPA such and such company, or something which has some brand equity, which would make the product which they have to offer a more attractive product in the market place that would allow them to differentiate the service, which they provide from the service which someone who doesn't engage in these practices, does not provide.

So kind of what we had in mind was something like this was to come up with a program where we identify certain criteria, whether it's training, IPM practices, adoption of some environmental principles, come up with a set of standards, number one. Number two, was go out to our membership and say look, if you can meet this set of standards, whatever they might be, then you can say I'm a whatever we're going to call EPA, you know, PESP member and advertise that fact and differentiate your product from somebody else's product and make it a more attractive product and create a market incentive for the PCO and the homeowner to do business with them.

Secondly, we'd have to kind of figure out a way to, I guess, validate, certify, or credit that somebody, in fact, was engaging those practices. And thirdly, beside just selling PCOs, we had thought that if, in fact, we got something like this off the ground, if we really had a program where there was an energy star logo that you could put on a PCO service or a lawn care service would be to actually go out to the public and try to create demand for that product where we might be able to say run public service announcements that say, you know, if you got a bug problem, you know, if you got a lawn care problem, whatever it might be, then do business with an EPA partner, maybe that's not the right choice of words.

I think that's a big step forward for the program and certainly goes beyond what the program has done to this point and while I don't expect to convince this group or, you know, I guess Marcia and Janet, you're the ones that I most need to convince, but today and here I think the idea of trying to create market incentives that would lure companies into this fold, number one, and two drive consumer demand for this kind of service holds out an enormous amount of potential in an industry like the one I represent.

So what I was kind of hoping would come out of this discussion here today wouldn't be any decision or maybe not even a whole lot of discussion, but I was hoping that we could consider the creation of a work group of some kind. I know we just had this whole work group discussion and maybe we don't need another work group, but the creation of a work group that could talk about this issue of trying to create a set of market incentives for companies whether the PCO's or commodity groups or whoever it might be appropriate for to try to move this program up to, I think, the next level of performance.

MS. MULKEY: Let me give you one just a couple of quick reactions to this, and then I think we, although we're borrowing time, I think we do want to hear from folks about everything they've heard.

What is this issue of EPA goal sales of approval is not a new one for EPA, actually it's a new one for the PESP OP program as far as we know. We haven't been asked in the kind of comprehensive and specific way, maybe we have.


MS. MULKEY: But in any event, it's not new for the agency, and there has been a lot of thinking and sort of legal research and guidance development, and certainly one thing I think we can and should do is try to capture in some sort of user friendly format sort of what are the limits under which we operate. I mean, it's not a never no way no how, but it's also not easy. There are a number of constraints. There are a number of considerations that are limiting. And I think we ought to invest in --

MS. ANDERSEN: We explained that I think to Bob, we could put it out more generally. We explained it to a number of partners and have been able to work out, usually work out arrangements that work for them. But I do think that there is an issue on the other side that I think just as much as you'd like to have one, the Armed Forces Pest Management Board is one of our partners is sitting at the back, they'd like to be able to use a local, because they have a memo of agreement with us that actually if we could come up with ways to identify IPM produced produce, they would consider selectively using that in their purchases for their armed forces for their commissaries and other sources, which could mean money to growers to know that the Department of Defense was willing to preferentially purchase their commodities if they were IPM grown.

So it is an issue that we need to work on.

MS. MULKEY: I think the starting point would be to figure out what kind of constraints are we all living with in a way that everybody sort of has a common understanding, and I think we need to invest in doing that in some form of writing. I'm not talking about anything very elaborate.

The second thing is to pose a question to you. Has your trade association thought about whether it could develop such a program independent of the government?

MR. ROSENBERG: Yeah, we have, and actually I think we probably are in a position where we would consider doing that. The problem is NPCA doesn't have the brand equity of EPA. So that's the first set of issues for us. And, you know, obviously we're trying to leverage your credibility to get our members to do something that they might not otherwise do.

Secondly, you know, I think this is pretty well known. There is a bit of a legal issue, and I think this probably goes back to 1992, and I think that's probably the genesis of the issue, but the development of the EPA lawn care advertising guidelines that arose from Senator Leiberman's hearings and some legislation back in that time frame.

As a result of the development of those guidelines, we have generally cautioned our members since that time to avoid any health safety or environmental claims in their advertising. Now, that's not to say that they all have abided our advice. Some of them still make health safety or environmental claims. Because of that, though, there are a number of state attorneys general who have expressed an interest in the kinds of advertising claims made by PCO's.

So without some sort of government imprimatur, it's a little bit risky for us to try to provide our members with some kind of a, whether it's a logo or statement that they could use that would constitute health safety or environmental claim that would run afoul of state attorneys general requirements.

MS. MULKEY: Well, let's have some discussion on this. We are basically committing ourselves to a little extra time together today depending on public communication. So that's -- but I assume there is some interest in engaging in some of these issues. I'm going to call on you. I just want to be sure we get a sense to everybody. Okay. Jacqueline.

MS. HAMILTON: Gosh, am I really the only one who -- I think this is one of the most exciting things I've heard in any track meeting or PPDC meeting that I've ever attended, and if we could have had this sort of discussion a year ago, we could be a whole lot farther along I think then we've gotten.

So I want to thank all of the presenters and clearly all of the very thoughtful work that's gone on in the part of the people that the presenters represent toward really trying to think through what is -- how do we move into the next century in the healthiest way, and although I'm not sure that a work group will work, I'm not ready to address the process issue.

I'm very excited by what Bob talks about in terms of wanting, NPCA wanting to develop and would hereby volunteer should such a thing be formed to work on that. Residential exposures are one of the big risk drivers, for example, on the OPs, and it's one of the things that we're very, very concerned about.

MS. MULKEY: Maybe they would like to have in our DCs.

MS. HAMILTON: We don't do that. We'd be happy to help out, but, again, there are constraints there, too, as you said.

MS. MULKEY: I suspected that, which was one reason I said that. I didn't want to be the only one seen as, well, what's wrong with you guys.

The very issues that Bob himself, the issues of concern about credibility and unfortunately he's going down a road that's difficult to go down, but I like the fact that you're --

MS. HAMILTON: I'm so excited, that I'm ready to step up to the plate to try to figure out how and if, I mean, I suspect it would take a lot of really hard work, and we certainly couldn't reach agreement on it tomorrow, but to figure out how and if such a thing might be possible, because I think that holds out a lot of potential.

I know I go all around the country and on radio shows and so forth I talk about pesticide issues, and one of the big questions I always get is, okay, so what do I do, how do I know. You know, I live in an apartment building built 50 years ago. I got a cockroach problem. I've got small children. I don't want to be exposing them to nasty things, but neither do I want them to be living, you know, having cockroaches crawling over them as they nap, what do I do, and it's difficult for me to go through the list of criteria that some people, for example, have developed about, you know, here is how you interview your pest control operator to try and figure out whether or not they are going to use practices you should be concerned about.

You can't do that with a broad audience, you know, in a half hour radio program or in a speech. It's very difficult, and so trying to address that on a more systemic level I think would be a huge positive step in the right direction, and I'll be very happy to work on it.

MS. MULKEY: You started yourself a side bar partnership if nothing else here.

MS. HAMILTON: A lot of work between here and there, but it's worth doing.

UNIDENTIFIED MALE SPEAKER: Janet, you know, looking through the list of partners, I don't see very many people from the academia here. I see the University of Georgia listed.

MS. MULKEY: Where else do you need to go?

MS. ANDERSEN: There is nothing stopping you from joining.


MS. ANDERSEN: There is one --

UNIDENTIFIED MALE SPEAKER: Do you have communication with everybody, the university?

MS. ANDERSEN: As far as the recruiting effort, we've actually not done a lot of real hard recruiting. This is much more been by word of mouth than it has been with us. We don't send people out on the street stumping to join the environmental stewardship program. We've got lots of groups who have joined, and I'd rather have fewer really good partners than a lot of so-so.

Now, that doesn't mean academics couldn't be really great. One of the categories left is the supporter category. I think more academic groups would belong in that, and when you look at it, there is a couple there that actually do really fit a little bit more, the IPM institute of North America is actually a coalition of people as I understand it, and the northeast research extension and academic program. So there are others that are more of a coalition, but we'd be glad to have them.

MR. JONES: Janet, if I could add, yeah, in the context of many of the commodity groups when a program is put together, historically we've always involved academics. It's all driven by academics in reality, because most of us don't have the wherewithal to be able to conceive of what the next step is, what's out there in the future. So we in our pear programs, peach programs, tomatoes, in beans in the midwest, we relied largely on the universities to be our partner in this process.

UNIDENTIFIED MALE SPEAKER: I know. That's why I'm surprised.

MR. JONES: Well, but they are partners with the commodity group. So the name isn't there, but the workload is. So maybe you want to get some credit for it, that's a good idea.

MS. ANDERSEN: That's really true in all kind of these, academics are really there supporting virtually every one of these programs.

MS. MULKEY: One of the internal discussions we've had is what I call wholesaling versus retailing, and essentially we're operating in a retail, you know, we're forging a lot of individual partnerships, although some of them are at a scale that then has a trickle through.

And so one of the questions might be, should somebody take the leadership of trying to sort of serve as an intermediary between us and this program and a multitude of academics in a way that basically spreads the word, or should institutions like states or academics run their own version of this program.

Now, you couldn't get everything. You couldn't get an EPA employee as your liaison out of that sort of second tier, but you might get some of the other elements of the program. So those are the kind of things that we've talked about without having any magic bullet answers. Bill?

MR. McCORMICK: Yeah, I have kind of a comment and question for Bob. In your discussions you concluded some sort of logo thing might work, to me that's a kind of a pull strategy kind of deal, and did you consider other kinds of pull opportunities like creating a demand in consumers that then ask the PCO to use this particular kind of pesticide, IPM kind of strategy?

MR. ROSENBERG: Yeah, we've actually thought a lot about this, and, you know, just say two things are sort of related to the question, Bill. One is this might sound peculiar, but actually this is going to take quite a selling job within our industry, because there are guys who don't want to have that logo or don't want to go through the red tape to get that logo, and they will resist this.

So it's not a given that we're, you know, going to have an easy time. It's not like we're kind of holding up the gravy train, all we need is EPA to sign off, and they are just going to jump on the band wagon. So I think that's a first given.

The second was we approached this with the idea that what we wanted to achieve was something that was meaningful and significant risk reduction. And something that was measurable. And we thought to ourselves, we can do another school IPM video, and we will do them, but, is that going to alter 10 companies or 100 companies or 1,000 companies behavior and if so, in what way and is it measurable, and we kind of reached the conclusion that no, it's probably not something that is going to achieve the kind of meaningful change that we're looking for.

The final point is that NPCA is actually in the process of raising somewhere in the neighborhood of 10 to $15 million, which I guess everybody will start seeing signs about in the next six months or so, where we're going to be engaging in what we call an industry awareness campaign, which will be a national advertising campaign, which we'll talk about hiring a professional.

And so we have looked at that as an opportunity to sort of push consumers not just to a PCO, but to a particular type of PCO. The problem is at this stage as a trade association, it's very difficult for us to say, you know, do business with our members, but just some of them. And that's part of where bringing EPA in makes it a more attractive alternative.

MS. MULKEY: Very interesting. Well, this has been terrific, and I hope we'll have some opportunity for further discussions of this approach to behavior change, because you notice that was the common thread in everybody's perspective on this.

UNIDENTIFIED FEMALE SPEAKER: One last thing. The last time I looked PESP was grossly underfunded. I haven't looked in about a year, but I don't know if EPA is at all planning on as a part of it's overall FQPA transition strategy using what is clearly a great little gem or nugget of a tool to try and get out there and show people that, in fact, there are ways to try and do this that aren't going to mean the loss of your livelihood. I haven't heard it if that is the case, and if not, then I strongly encourage EPA to really --

MS. MULKEY: There is no major new funding initiatives in this program in either the present 2000 budget or any budget that I'm aware of.

UNIDENTIFIED FEMALE SPEAKER: And just like over at USDA neither is there adequate funding. You know, there is some great stuff going on out there.

MS. MULKEY: Well, this is one reason why we've had this whole set of retail discussions and some of those kinds of things, is even if we had some boost in funding, it's not like we're going to be dealing with the kinds of dollars that can buy all these behavior changes. So whatever happens on the funding front we've got to find ways to leverage this beyond, you know, even one commodity at a time.

MR. JONES: Can I respond to that briefly, Jacqueline, in one sense what EPA is trying to do is develop some models, and the idea here is to use this as seed money so that we take some great ideas and move them in other locations. It's also -- that's also being done by Larry's group. It's being done by World Wildlife Fund and the WPBGA project, and ones we're all involved with, so there is lots of various models going out there, and I'm sure PESP would love to have some additional funding, but at the same time, there are some great things being done that won't need PESP funding. Maybe we can all become members, you know, all these little groups become partners.

MS. MULKEY: I actually asked people, would it really change your involvement if instead of your having gotten a 30,000 grant, you got a 20, just because, you know, if every marginal dollar you can maximize.

Bill, you've been quiet all day. So we'll definitely let you.

MR. TRACY: An old cowboy has got to say something. Probably to answer Jacqueline, I think a vehicle that is really useful in getting this type of information out was Dr. Amador's concern. Our university extension services is a tremendous vehicle for imparting this information to the users out in the field.

As an example, my family farm has been using IPM since 1952, and that was because of the university. And back in the old days when we had selected pesticides, we were releasing predators, lace wing, big eyed bugs, -- (inaudible) -- and all to go out there and do the jobs that pesticides did. So it's not a new idea.

And so we need to look at concert, I would suggest working in concert with our extension services to get this work out, our 4-H people. That's why we created 4-H, because all the old geezers wouldn't change their ways, so we got to the kids and changed their attitudes back in the 1930s when 4-H was formed. So that's, I think, a great partnership to work with is all our universities.

UNIDENTIFIED FEMALE SPEAKER: If you'd like just a brief comment. We really consider these two initiatives, the 75 percent adoption and this program to be really joint where USDA, EPA, and FDA, and we try to keep as much of the information as we possibly can going out to all kinds of IPM activities through ASDA like Fitsner, who is actually on sabbatical right now sort of actually helping out when Garrett Cooper has been gone in Oklahoma, but he'll be back. He's the national IPM coordinator. Also coming on sort of a hopefully full time in October. I sit on their committee so that there is a lot of discussion back and forth in trying to get all this information out so that every time we have grants that go out, the grant programs, they know about it, et cetera. So they are really working on it. But always can do more. I think that that's true.

MS. MULKEY: Dan, could you do a quick last word?

MR. KUNKEL: Just one quick clarification. There are some partners who are in it even without going for the grants, and there is a lot of benefit, and a lot of process involved that grants would be nice, but we're going to stay there whether we ever get any funding at all from EPA, don't ever ask us to pay for the privilege of being near you, but at this point even there, that might not be that far down the road.

MS. MULKEY: Great. That's a nice note to end on, that subject. Well, we have three people who signed up for public comment, four people. What I suggest we do is we take those, and then we decide collectively whether we want to take this last topic, and somebody has come to present it, and it's one you asked for, but public comment is supposed to be limited to two minutes. So we should be able to get through that in the next six or seven minutes, and have only the half hour that was scheduled occupied by this last topic.

So why don't we go to that. I'm going to call on folks in the order in which they signed up. Starting with Chip Collins of the Stepan Company.

MR. COLLINS: You really addressed my concerns, and I just wanted to thank you for adding Warren to the PPDC, because we were very concerned on the inert disclosure issue. It's really from the standpoint of how it will be disclosed, it's the responsibility of the registrants, the label holders, but a lot of the confidential information is held by the -- (inaudible) -- manufacturers that represents two to five percent of composition of a lot of the pesticides, and with representation we feel like we'll, you know, we'll have our say.

MS. MULKEY: Is that what your company does?

MR. COLLINS: We do. We manufacture surfactants. I guess there were probably six represented here today, and there is probably list three and list four inerts, which most of them were in our bailiwick. There is probably 10 to 12 manufacturers.

MS. MULKEY: Do you feel comfortable telling us what size company you are?

MR. COLLINS: We're 657, $700 million in sales, but only a small percentage of that's pesticides. Most of our surfactants go into products probably everybody in this room used today from toothpaste to shampoo. That's most of what we make, but the same types of ingredients go into pesticides.

MS. MULKEY: Okay. Thank you very much.

Gerry Miller of the California Department of Food and Agriculture.

MR. MILLER: Good afternoon and thank you for allowing me to address this group. I'd like to say I am a member of the California Department of Food and Agriculture as well as the stakeholders work group for the rodenticides. I'd like to commend Lois Rossi and Michael McDavit on their fine job that they have done in keeping that group focused and, you know, it's like herding cats at times. And it is a very big job that they are doing, and we do believe that they are doing a fine job at that.

I'd also like to say that we look forward to continuing working with this group, and as a member of the rodenticide registrants task force in pursuing improved label language and continued outreach and education and, again, I'd like to thank you very much.

MS. MULKEY: Eileen Moyer of Reckitt and Colman Incorporated.

MS. MOYER: I'm Eileen Moyer with Reckitt and Colman. I'm director of regulatory affairs. Reckitt and Colman is manufacturer marketer decon products, and I, like Gerry, am a member of Rodenticide Stakeholders Work Group, and I was basically he took some of the words out my mouth. I was going to commend Lois and Michael and Dennis Diesel for the fine job that they have done in moving the process along, keeping control of the process. Those meetings have been run very well, Marcia, I think you should know that.

The process was very successful in identifying the problem. If you look at the rodenticide cluster RED, there was a premise that was put out in that RED that the AAPCC data, the association -- American Association of Poison Control Data indicated that there was a problem with rodenticides. We went through a lot of painful discussions at the stakeholders panel meetings and at the second meeting that we had, there were some educational presentations that were given, which really highlighted the fact that the problem isn't necessarily the toxicity of the formulated anticoagulant rodenticides, because the product that you may use in your home really has an extremely low level of toxicity.

It's also not the problem with adverse affects from exposure. While there may be a high number of incidents reported to AAPCC, that doesn't necessarily mean that there had been adverse affects or clinical affects from those exposures. And a lot of that was brought out in the meetings to make it clear to help identify what's really the problem.

And I know, Bill, you had a question on the use data, and placement, and really the issue is really keeping these products out of the reach of children just like any other product in the home. And when you look at these products, there is no more risk from these types of products on an incident basis or a toxicity basis than there is from any other product in the home.

However, we do want to keep things out of the reach of children. We do want to reduce risks no matter how small the risks may be. So when we look at opportunities, we really feel labeling has to be improved as many of you know, the labels, we have a lot of mandatory language we have on our labels, but we have a lot of other things that go with that language, marketing language, and there are ways we need to simplify, make the message clear to the consumer on how to properly use a product. So we do endorse what was put forward to you today, and I'm very happy to see that you have approved that first step for risk mitigation so that we can move forward and make some progress, and Reckitt and Colman also does support the use of education outreach programs that may already exist.

We may not have to recreate the wheel. What do we have in place, and one of those is the CLI process that we can use to read the label program. There are other opportunities, National Safe Kids Campaign. So we need to be creative and look at some of the opportunities rather than recreating the wheel. And we do want to encourage you.

On the table there was a document from the Rodenticide Registrants Task Force, which had some of the presentations that have been given to the stakeholders, and I do encourage you to read that information which looks at the incident use data. It looks at the toxicity of these products, the usage, and also there is an example of a simplified back label panel. So you'll see a before and you'll see an after. So it just gives you some ideas that we have been working on.

I do have a second comment that I'd like to make that has to do with the process of the PPDC and the formation of work groups. When I heard some of the comments about the inerts work group, and I'm extremely interested in inerts not just for rodenticides, but Reckitt and Colman also markets Lysol brand products, the work groups need to have a very broad representation, and one of the problems that we've seen, and we saw with the rodenticide work group was that there is a limitation on who can participate.

So I was a little concerned, Marcia, on your comment about encouraging a broad number of people on this panel to be on a work group, which would then eliminate the seats for other stakeholders. So while I do recognize that some of the people on this PPDC panel may want to be part of work groups, if the more people from PPDC who participate, the less opportunity for other stakeholders to participate, because these panels are limited. Thank you.

MS. MULKEY: Just to clarify, I wasn't showing a bias either way, whether it was a lot of membership from this group or none, but just trying to get the group to engage on how you thought best to deal with that.

UNIDENTIFIED MALE SPEAKER: Did she mean the inerts work group or the inert work group.

MS. MULKEY: Well, she was talking about -- what did you say?

UNIDENTIFIED MALE SPEAKER: I said is it the inert work group.

MS. MULKEY: He's trying to make a funny. That other work group is not a bunch of rads either. All right.

Adam Goldberg from the Consumers Union.

MR. GOLDBERG: Yeah, I'm Adam Goldberg from Consumers Union. At Marcia's suggestion, I just wanted to introduce myself to all of you. I know that you've worked with my predecessor Janine, and I'm looking forward to working with all of you in the weeks and months to come. Thank you.

MS. MULKEY: Thank you. All right. That worked. We now have the half hour that our agenda said. I know you're flagging, but you were very interested this morning about issues related to the international dynamic having to do with pesticide products and issues relating to our determinations about health and safety and environmental issues on pesticide products in the international arena, and issues relating to what's available internationally that might come into our borders.

And so I hoped that you've sustained that interest in anticipation of this presentation, which some of you asked for regarding two major international activities the PIC and POP. The Prior Informed Consent, which is not a new concept. Obviously it's a very important part of the whole issue of movement, of everything from hazardous waste to toxic or potentially toxic materials.

The POPs stands for Persistent -- help me out, Organic Pollutants. And it is then a subset of pollutants that raise concern because of their chemistry and their persistence. And so I'm not going to go any further so I don't show any more of my ignorance.

MS. JENSEN: Can you hear me, or do I need to carry a microphone?

MS. MULKEY: This is Janice Jensen. People have been operating without a microphone at that station.

MS. JENSEN: The treaty and the overheads that I'll be talking from are on the yellow sheet of paper.

These are, as Marcia said, persistent organic pollutants. These are chemicals that are -- there is a consensus that these chemicals are problematic enough to warrant global action. These are chemicals that there is consensus they can't be controlled through domestic regulatory action or even regional regulatory action. There has to be control through a larger global system. And so this is a treaty that is in the process of being negotiated, and the negotiations are being run by the UNEP, which is the United Nations Environment Program.

The negotiations for this treaty started in July of 1998, and there is agreement that the treaty negotiations will be unlimited for 12 different substances. You can see these are chemicals that most of us are familiar with. Some of our older organic chemicals, such as -- (inaudible) -- as well as industrial chemicals like PCB's and hex four benzene, and then there is byproducts of the combustion and then the dioxins-furans are byproducts of combustion and industrial processes.

The negotiations -- we're in the middle of negotiations right now, and the next negotiating session will be in September, and at this point what we're trying to do is to develop treaty texts, because this is a legally binding instrument, and we've developed texts, the UNEP developed the first round of text. We're providing comments on it and we will get into very serious discussions of the text, making proposals for the text in September.

One of the things that I'd like to do here for you is just to give you just basic information and provide you information where you -- provide you internet sites and other sources so that you can go and get more detailed explanations of the treaty, and you can be a participant if you want to.

At the first negotiation, they set into place two different groups, and the first group is the criteria experts group that basically was trying to set up the scientific criteria and a process for additional substances, because it's envisioned that there will be additional substances that will be added after the treaty is negotiated, and so that's what the criteria experts group was setting up. The scientific criteria that would be transparent, because the point is that we're trying to get chemicals that justify a global action, not things that just can be dealt with domestically or regionally. So we would expect a very stringent set of criteria for these difficult to regulate chemicals.

And then for the implementation issues, these are many of the developing countries might need some assistance to implement some of these obligations, and so the implementation group will be working on a variety of implementation activities.

And the negotiations and discussions for the implementation group have just begun. They are far from being complete. Criteria expert group exceeded everybody's expectations. They met twice, and have basically completed their work and their report, which if you look on the internet site that I have on the next slide, the website has all the various documents from all these different negotiations. And if you're interested at all in the criteria, then it's all up there, and it provides especially the earth bulletins. They provide a country by country specific information about what happened to each of these negotiations. They are very detailed and very good.

Now, the treaty negotiations began in July of 1998, and expectations are that it will be completed at the end of the year 2000. There are going to be three future negotiations. The next one, as I mentioned will be in Geneva. And then there will be a March negotiation in Bonn, and the final negotiation will be in November in South Africa. The location is still somewhat tentative. But it's expected at that point we will actually have a legally binding instrument for controlling persistent organic pollutants.

As I mentioned, there is the UNEP website and the earth bulletins. I guess one of the big messages I'd like to bring to you is that there are ample opportunities for public participation, and we would welcome your participation. There is a formalized process for participation and it's run by the State Department, and we encourage you to sign up. Trigg Talley, his name and telephone number and e-mail are on the more detailed sheet.

And what we do is we have briefings before and after each negotiation. Many of these are conducted by speaker phones. So if you can't afford to fly in or choose not to fly into the Washington area, you can participate and use a speaker phone. And then actually at the negotiation, we meet with U.S. NGOs or other stakeholders actually during the negotiations. It usually works out about once a day that we meet with interested parties.

So I just want to let you know there is ample opportunity for public participation and with that, I will end because I know everybody is tired.

MS. MULKEY: We want to hear from Kathleen and leave a little bit of room for lively enthusiastic involvement of this group.

MS. BARNES: I appreciate that, and I appreciate all of you hanging in for the very last presentation of the day. It will be my challenge to see if I can keep you interested until the very, very end.

I'd like to point out that there is a fundamental difference between the POPs and the PIC. And I'm Kathleen Barnes, and Janice and I work in the Government and International Services Branch of the Field in External Affairs Division of the Pesticide Program. There is a very big difference between POPs and PIC.

In the POPs, as I think Janice pointed out, what you're dealing with is a global treaty dealing with risks that are of a global nature. And with the PIC, which stands for Prior Informed Consent, what we're dealing with there is primarily an information exchange instrument based upon national decisions about risk, and also fundamental to the PIC is the making information available to all parties that have participated in the procedure. So whereas POPs is more global in nature, PIC is nationally based, but eventually becomes very much an international instrument in that many countries we have seen are taking very similar actions based on the information that is provided to them through the procedure.

The official name of this agreement is the Rotterdam Convention on Prior Informed Consent Procedure for Certain Hazardous Pesticides and Chemicals, I should say, in the handout you have, I'm sorry if there is an error in it, certain hazardous pesticides and chemicals in international trade.

I've also distributed another handout, which provides more basic background information on what PIC is, and it includes as an attachment the pesticides and chemicals that are currently included in the PIC procedure.

The U.S. was one of about 60 countries which signed the agreement last September, and its entry into force is dependent upon ratification of the agreement. Internationally it will enter into force once 50 countries have ratified it, and we expect that that will probably take about two years.

Clearly the U.S.'s involvement, and its legally binding status in the U.S., is dependent upon our ratification of the agreement. So technically at the moment we are signatories to the agreement. We are not parties, and we will become parties if and when we ratify it.

It was interesting, we had a meeting last week in Rome, and it was very interesting to note that Gambia announced that it was the very first country to ratify the agreement. So there was quite a bit of praise for that country's quick action.

The convention does build upon a voluntary procedure that has been in existence since 1992. And I should say that I think the voluntary procedure in turn was modeled very much along the lines of our FIFRA Section 17 program, which provides for notices of control action internationally, and also provides for export notifications about unregistered pesticides.

The big difference here in the PIC is that they are dealing with a limited set of substances that must be banned or severely restricted as defined by the convention. The agreement establishes a procedure to promote shared responsibility in the international trade in the certain substances that are listed through an exchange of information and communication of national decisions about whether or not countries want to permit import.

And although the obligations really are limited to those substances that are included in the agreement, the channels of communication have been established. And I think it is very fair to say there is going to be and there has been quite a bit of information exchanged about pesticides, about industrial chemicals, about many actions that don't rise to the standard that is set in the agreement for a ban or a severe restriction.

As I noted, the basic obligation established by the PIC procedure will be once a pesticide or a chemical is added to the list and a country indicates that based upon the information that has been provided to them by the secretary and approved internationally, if they choose not to permit import, the exporting country is obligated to prohibit export to that country.

Also included in the agreement, as I noted, it's a very dependent on information exchange, there are other provisions which relate to export notification when a country bans or severely restricts pesticide or a chemical, we are obligated to provide some export notification. It also raises the standard for labeling requirements, which I think I'm proud to say that we're raising many of the international standards to meet the U.S. requirement that in the past there have been many countries that have exported without any information provided on their products, and it also provides for some basic information that is generally provided now on a voluntary basis with material --

(End of tape.)

MS. BARNES: -- in the voluntary procedure and throughout the negotiations we've enjoyed pretty strong support from both the industry and environmental groups. As Janice mentioned, we have this procedure in place to encourage public participation throughout the negotiations, and environmental groups and industry are present in the meetings as observers. And usually the way it goes is after all the governments speak, which can take forever, as you can imagine, the observers do have an opportunity to comment on some of the proceedings.

The handout indicates that we currently have 22 pesticides and five industrial chemicals on the list, and I'd also just like to point out, and I think I want to be really brief about this, the agreement established in interim procedure acknowledging that we were going to be in a transition phase from a voluntary program to one which hopefully will become legally binding, and that interim procedure is now in operation right now. And last week in Rome we considered the future of six pesticides, which had been left in sort of a limbo status when they weren't officially approved by the time the agreement was signed, but nevertheless had been through different levels of review by the international technical body that was looking at them. Some preliminary decisions were made. All of these decisions are dependent by final approval by the conference of parties. So this is a provisional and interim procedure, and those decisions were to add two additional pesticides to the list, toxaphene and benefrocil (phonetic), neither one of which is currently in production, which is of some concern, because we don't want to be spending international and national resources looking at chemicals that are totally dead. But there was some indication that since some work had been done on them, there was the prospect of production being initiated in some countries. We wanted to at least be able to share information about those pesticides.

And just quickly to note, in terms of the current status of our own legislative activities on this, the way this usually proceeds is that the State Department prepares a formal transmittal memo to the White House, which recommends that the agreement that has been signed be sent forward to the Hill for formal advice and consent of the Senate, and that transmittal memo has been prepared and is in the process of making its rounds interagency. We are seeking interagency comment.

As I noted, we've had some -- quite a bit of history with this procedure, and many other agencies were at the table with us throughout the entire negotiation. Implementing legislative language has been drafted, and it's under review. And our goal is to have it to the Senate this fall. I've also noted in the handout where you can get more information about PIC. There is a PIC home page that is maintained by a joint secretary of the UN Environment Program and the UN Food and Agricultural Organization. And I'm happy to answer any questions if that's appropriate.

MS. MULKEY: Let's have some comments and questions if we have them on these topics. Ken?

MR. ROSENBAUM: First of all, thanks for the briefing. I think that the POPs is an idea we should be supporting. From a very personal point of view, over the years I've missed two of these meetings, because I was overseas in Bangladesh during mosquito season. And to be in a country where the front of page of the newspaper shows teenage boys, who have collected 40 pounds of mosquitos because it's so bad this year, and you're faced with sleeping under a net, of course, but if you're going to walk about the house on ordinary days, you look at the can of pesticide, and you kind of decipher the local alphabet, and you see that the ingredients list lists biocide W, and you're kind of pondering, I wonder what that is, and it's obviously something that they don't particularly want you to know about. It would be nice to see some international standards on what pesticides ought to be used. It would be nice to see some clearly bad actors banned and not coming back to us in the imports.

Two questions. Any sense of what other compounds are likely to be added to the POPs list, and could you comment, could you explain how the enforcement mechanisms are likely to work?

MS. JENSEN: I wish I could answer both of those questions, but I can't, because they are just trying at this point to come to a consensus on the actual criteria that will be used for an addition of substances as well as the process for that. And so we don't really have an additional -- we don't have a list at this point.

It would not be unreasonable to expect that chemicals that are being considered in a regional treaty, which is LRGBAP Long Range Grounds Boundary Air Pollution, and it's through the UN Economic Commission for Europe. It has more substances than are being considered in the global POPs. So it's not a stretch to think that those additional substances might be considered as a first tier of chemicals. But I have no insight as to what will happen.

Chemicals that were included on that list were lindane, and the other isomers, as well as kepone, those were considered on the LRGBAP list. Pentacor fenol was included in the body of the LRGBAP text. It was not included in one of the annexes. So those are the chemicals that could possibly be considered, but I have

-- we will go -- I'm sure they'll have a specific group to make that determination.

As far as the enforcement mechanisms, we haven't worked those out yet either, because we haven't agreed on the text yet.

MS. MULKEY: Larry?

MR. ELWORTH: You didn't make a big deal of the fact that based on this information, countries can refuse entry of these chemicals based on their own regulatory schemes, which I think is also important. I think my experience at this is that this is an especially good example where industry has been really helpful, played a real positive role in this. I know a couple of people from ACPA have been very strong contributors both technically and in terms of support for it.

I was interested to hear about the ratification. I was curious if this is -- how it turned out if this was going to require any changes in FIFRA as a result of ratification.

MS. BARNES: Just to second the first point you made, we have really enjoyed the support and involvement from all of the interest groups, and Richard Neilson (phonetic) from the Global Crop Protection Association has probably been to every PIC meeting that there ever was and has been a really valuable resource for all of us.

And, in fact, I think one of the reasons why we have moved into a legally binding regime here is that the voluntary program was supported by many. I mean, I hate to say this, but it's almost a no brainer to suggest that industry would be knowingly exporting their product to a country that says it's illegal. Our industry tends not to behave that way, and what we're trying to do is to encourage that same commitment by industries all around the world.

And in terms of the changes to TOSCA and FIFRA, I think there are currently many things that we can do with the current statutes. Certainly export notification is one. Labeling requirements is another. But I think that it was determined that the part that's missing is to actually have the authority to prohibit an export in the face of an importing country's decision to say no, I don't want it. It will be our obligation to say to our industry, you are not permitted to export to that country.

MR. ELWORTH: Will that require FIFRA change?


MR. ELWORTH: In both cases. So what would be the process after ratification? Would you ratify it and have the amendments to both statutes?

MS. BARNES: That's the ideal situation apparently, and I've never been involved in one of these before, but there has been instances where I think in the chemical weapons agreement, we ratified that agreement without implementing legislation. So we're kind of in a difficult position there. The ideal situation is to have ratification and implementing legislation at the same time.

MR. ELWORTH: Is there consensus on what the implementing legislation would look like?

MS. BARNES: It's still in draft form, and it's still under review within the administration, but I think the idea was to keep it clean, to limit it to what we had agreed to do in the agreement itself. And so we're calling it the clean PIC, which will create the very necessary obligations to meet our responsibilities under the agreement.

MR. ELWORTH: Has industry been fairly comfortable at least with the direction?

MS. BARNES: As far as I know, and in fact more than comfortable. I think they've been very supportive, and as was shown last week in Rome, there is a broad difference of opinion about how things ought to be treated, and I think that the U.S. takes these negotiations very seriously. And when we go into a negotiation, we agree to a text when we know that we can live with it back home, and we don't agree to a text that we cannot bring home.

And I think that other delegations, whose names I will not mention here, but other delegations look at things differently. And so it was very clear that it is in our interest to be a party to this, because we want to be able to uphold a solid standard for the agreement.

MR. ELWORTH: The agreement has also reinforced a level playing field for all the countries, the chemical producing countries as well. I think that's another reason there has been support for it.


MS. MarshallL: I was wondering what current provisions there are for exchanging information on pesticides and toxic chemicals and testing.

MS. BARNES: Well, it does vary. I mean, we do have our own statutory obligation to provide information worldwide when we take notices of -- when we take regulatory actions, we send out notices about those actions and offer additional information upon request. We haven't limited our notifications to just the most serious ones. We've provided information just on a FYI kind of basis. But I think beyond the UN program of designated national authorities, which has been very helpful in figuring out who in Gambia I should talk to if I've got a question about a pesticide regulation, there are other programs in existence, and Anne Lindsay has been the chair of the pesticide forum of the OACD. That is a group comprised of all developed countries, that's where you're having more information and review sharing and such.

Also on a more regional basis, we have the NAFTA program, where there is more work devoted to harmonization of requirements and sharing of reviews. I think it's in the PIC where we reach out more to the developing countries to provide them with more information that they may not otherwise have.

MS. MULKEY: Well, thank you all. Thank you for hanging out. I hope you enjoyed seeing some faces from the pesticide program that are a little different from the usual suspects, give a sense a little bit about our breadth and depth. I hope you found the topics met your expectations, and I look forward to hanging out together again tomorrow. We do have a fairly leisurely start, 9:00. And so I trust that everybody will be here exactly at 9:00, and in our seats. Thank you.

(Whereupon, at 5:30 p.m., the meeting was adjourned.)











DAY TWO - JULY 22, 1999

MS. MULKEY: Thank you, you loyal who heeded the request to be exactly on time. We have a very dense session for this morning, so it's important to get started.

I'm glad Jim is here with us today -- not in those one or two places -- as I said yesterday, there was only one or two places that would -- (inaudible) -- you be here, and that's where you were for part of yesterday, but we're glad you're here today. Theres Murtagh is here for Keith.

MS. MURTAGH: Keith might be here.

MS. MULKEY: Good. And Bob Lake told me that he was going to try to be here part of today, as well. So, it's good to have all our federal partners with us.

This morning's session is worker risk assessments session. For those of you who either are part of the TRAC or follow it closely, you will remember that at the last TRAC meeting -- as part of our presentation of a couple of the organophosphate refined risk assessments, the portion of the risk assessment that related to estimates of risk to workers was somewhat eye-opening and concerning to a lot of participants.

And there was a feeling that we had invested a great deal of time together in understanding how dietary risks are estimated, and that there had not been a comparable exchange of knowledge about the way we go about trying to understand risk to pesticide handlers and other workers who are exposed to pesticides by virtue of entering treated fields and that kind of thing.

And there was a commitment at that session that we would work at the same level of transparency in this part of our work that we have tried to achieve in the other parts.

Today's presentation is a part of that, but it's not intended to be the one specific major public presentation that would fulfill that promise.

But it's -- what you're going to hear is some things about our processes, the ways in which we're going about trying to improve transparency. Then we do want to do a presentation on how we do estimate worker risk so that we, in effect, begin to do some of what we say we're going to do regarding --

And then we've asked Nelson Carrasquillo whose group has done some analysis of the worker protection rule and other matters relating to workers in the area where they have responsibility -- and by a member of the industry task force which has been generating, and now submitting, data relating to the pesticide exposure from foliage and that kind of thing.

So, that's the presentations. That's quite a lot, we know. We're going to ask all the presenters to try to be as tight as possible so that -- tight is probably not the right word -- as efficient as possible so that we'll be -- (inaudible).

I only want to add one other thing. In EPA's presentation, we are presenting the results of analysis of a particular pesticide; in fact, one of the organophosphates.

To illustrate the way we do our work, I just wanted to explain a little bit about why this one. It is Azinphos-methyl. It is the chemical on which we did the presentation at the TRAC and on which we've done other public presentations, including a technical briefing.

And so, it was selected primarily so that instead of making news, we could make an illustration here this morning. It is not unusual among the organophosphates. That is to say, it's not selected because it is, you know, the most significant in terms of worker risk.

All right, without further ado, Jay and Kevin are going to start us out with a discussion of what we're doing on process. And then we'll move to an actual presentation of how we do the worker risk assessments.

MR. ELLENBERGER: Thank you, Marcia. Good morning everyone. I'm Jay Ellenberger with the Field and External Affairs Division and OPT. I'm going to take a few minutes to inform you about our plans for opening up the dialogue process of how we do -- or how we estimate effects to workers for pesticide exposure.

We have a plan that goes over the next few months through summer dealing with a number of important stakeholders and starting with you. Let me put up an overhead that you all should have a copy of.

As Marcia said, we're starting this morning -- we're sharing with you how we estimate the risk to workers and have a discussion, not only with OPT scientists, but industry and farm worker advocacy groups.

And then moving into next week, actually, USDA and -- (inaudible) -- myself have been working together planning and meeting with USDA personnel and personnel -- key personnel from some of the land grant universities across the country. These are university and USDA personnel that are experts in the particular fields of -- that pertain to worker exposure.

We will -- we plan to share with them how we conduct our risk assessments, listen to their issues, and ideas, and suggestions. And also to plan for another meeting, which is later in September -- the end of September down in Baton Rouge, Louisiana.

There is a pesticide applicator training and pesticide impact assessment program meeting, which will include important trainers or education trainers from the states. Individuals who train applicators on safe pesticide use, worker protection.

And also, pesticide use experts. We want to spend a lot more time with them making sure they understand how we estimate risks and, also, to listen to issues and concerns that they may have about that.

So, again, it's opening up the process and dialogue for our own internal processing. Theres, do you wish to add anything to that?

MS. MURTAGH: Yeah. USDA has employed a lot of the land grant specialists to review some of the revised risk assessments. And they've looked at the dietary, the occupational, and the ecological risk assessments.

And some of our -- well, many of our people who review the occupational risk assessments know a lot about pesticide application, they know a lot about training. And they were confused by some of the points in the occupational risk assessments.

They wanted to know more about how the risk assessments were prepared so that they could become better reviewers.

But more importantly, they said they weren't really comfortable with being reviewers -- that they would much rather work with the Agency as contributors, and to understand what the assessment process was, and how they could fit in early on providing good information because they're out there. They know how pesticides are applied, and they know what's going on.

And so, this is one of the intents of the meeting -- both the planning meeting next week, and then, also, the broader meeting in September -- to work out a better process so that USDA land grant people can become better participants.

MR. ELLENBERGER: Any follow-up questions to that? If not, Kevin Keaney.

MR. KEANEY: I'm the branch chief with the Certification and Worker Protection Program.

There are two key regulations that we work with that cover workers that work around pesticides. The focus here would be the worker protection regulation for protecting agricultural workers. But we're also -- in which we're conducting a major national assessment.

And we're also doing the same with the certification and training program because there is a good deal of overlap, and we would anticipate the assessments of both programs would result in regulatory change and better integration of the two regulations and the two programs to more effectively protect workers -- workers around pesticides.

The worker protection regulation itself and the worker protection program is designed to focus on agricultural workers and protect them from the effects of pesticides, provide measures to mitigate exposure and to provide them with information.

It was a regulation that was long in gestation and was finally brought final in 1992. There was a congressional delay in full implementation, a period of label change to accommodate the provisions of the regulation. And then the full year of implementation. The first full year of implementation was 1995.

So, we're at a period where it would be normal to reassess a program coming out of that new regulation. We were planning a national assessment of the program to determine how effectively it was being implemented, how effectively it was being enforced nationally.

And our development of this plan for reassessment coincided with a number of studies, and petitions, and requests from organizations around the country that we do just this type of reassessment and try to focus on the ability of the regulation to protect children that might be involved in agriculture or exposed to pesticides in agriculture.

So, there's a basic reassessment that we're going to be conducting but with a certain focus on children and women involved in agriculture.

The way that we're going to conduct the reassessment is by forming a worker protection assessment group. We are beginning now to form the core federal participants in the assessment group with representation by EPA, USDA, Department of Labor, and the migrant services activities out of HHS.

We're at the stage where we will be involving the state regulators, our partners since these are delegated programs, in this process.

A great deal of the training and the information exchange that goes on in the worker protection regulation is conducted by extension service -- state extension service. They will be involved.

Farm worker advocacy groups such as Nelson's, service groups, training sessions that they conduct. They will be involved in this assessment with us.

And we do have out of our group a major new initiative in health care provider outreach. And so, we'll be involved in the farm worker clinician networks in this exercise and any others that we feel would be appropriate contributors to the process.

The goal of the group is to -- as I said -- assess the national -- the state of national implementation and enforcement of the program. We do feel there are states that have done a great deal in this respect, and there are others that have done less. And we would like a better sense of the norm and how we can effectively raise the bar so we have consistency across the nation in the program.

In addition to that, this particular group is modeled -- will be modeled on an exercise that we've been undertaking in the certification training program for the past 18 months.

And it's -- I think it has been a very effective means to focus attention on the program and work towards the second point -- and that is, generate a consortium of interest that can effect change in the program -- that can bring about change.

And it also would foster partnerships that would be essential to make this program work, and it will provide an ongoing focus if we are moving towards a point where we're trying to integrate a number of programs and provide a good umbrella of protection for workers around pesticides, then we do need some forum to focus on issues and resolve issues, and this group can provide that.

So, the function of the group is to facilitate the national assessment, develop a strategic plan for the program. And as a means of checking progress and so forth, we will publish reports out of this group as to how we are progressing and how the program itself is progressing because then ultimately we'll move to a point where there will be a better integration of the two regulations that cover the range of workers that are dealing with pesticides in this country.

Relative to the next presentations that we're going to be hearing on worker risk assessment, the initial regulation -- the 1992 regulation established interim restricted-entry intervals for the range of pesticides that are covered by the regulation.

The process that we're going through now is refining those interim restricted-entry intervals and establishing more of product specific and function specific reentry interval.

It's very important that you understand the distinction between what was established as a reentry interval in the initial stages of the regulation and the program, and what's coming out of the worker risk assessments that we're seeing now. They are based on a much more detailed assessment of the task, the exposure profiles, and so forth, and the use patterns.

So, there will be a number of -- there are a number of changes coming out of the process that we're working through in this worker risk assessment exercise. What we would like all of you to be involved in is providing adequate information to the process so that this changing from interim -- which were based on fairly rough algorithms to arrive at the interim REIs -- that they are actual reflections of what is going on in the real world use context with these products.

So, a number of you, I know, have been active over time in the program in the early stages. Jose worked with us on some of the training exercise and development of materials, and Larry has been involved in some of the frothing that went on to bring it to full implementation through a period of amendments.

And I would anticipate that a number of you will be called on to participate in the group and the national assessment that we're conducting now.

UNIDENTIFIED MALE: Can I ask one quick question because it's solely on this. One of the things that occurs to me when I look at this is that we talk about the national worker protection program that takes place by Office of Pesticide Programs under FIFRA.

But there are a number of other state right-to-know programs, there are Title II -- whatever -- (inaudible) -- whatever it is. And at least at the field level, it's not really clear how those programs can or should interact, and how to implement them at the same time with seasonal employees where you have three programs. Which one are you doing? I would hope that with that set of people there, you address that.

MR. KEANEY: Yes. we realize that -- that there is a great deal of overlap with other programs.


MR. KEANEY: There are a lot of right-to-know elements in the worker protection regulation and the labeling that we're coming out with. So, it is important that you have some sort of integrated federal presence bringing all of that information to bear on the assessment. Yeah.

UNIDENTIFIED MALE: Yeah, because you really do have everything from right-to-know, to protection, to actual field protection, to labeling. And at times it's not clear which program you're in when you're doing what, which doesn't really necessarily mean anything.

You don't have to know what federal agency is responsible. But in order to do a good job, it would help a lot to have that -- at least, thought about -- thought through at the policy level.

MS. MULKEY: Well, there will obviously be other opportunities to discuss this element of our presentation, but we're ready now, I think, to focus on the worker risk assessment process -- the chemical-specific worker risk specific process.

And we have -- (inaudible) -- of our key people, who, I guess, will introduce themselves as

they --

MR. BECKER: Thank you. My name is Jonathan Becker. I'm an environmental health scientist in the Health Effects Division of OPP, and I conduct some of the occupational risk assessments for my division.

What we would like to do today is talk about a little bit of background for the worker risk assessments, go into some detail on how we conduct a handler, or a -- sort of the pesticide applicator or mixer loader assessments, and then move on to post-application assessments. And that will be presented by Tim Leighton, sitting on my right-hand side.

In terms of background, I'm sure everyone realizes that worker risk assessments are required under FIFRA. And EPA has issued guidelines for agricultural reentry and applicator monitoring studies beginning in the early 80s and continuing with updates and revisions.

The assessment methods have been developed -- they are jointly developed between Health Canada, U.S. EPA, California DPR, and member nations of the OECD.

And I think it's important to realize at the onset that the same assessment methods that we use for re-registration of existing chemicals are the same methods that we're using for the registration of new chemicals that are coming through the pipeline.

UNIDENTIFIED FEMALE: Could you speak up, please?

MR. BECKER: On the next slide you'll see that we typically do two types of assessments for two different groups of people. First, the handlers, and these are people that mix and load pesticides, that apply pesticides. And they can be either commercial applicators who handle pesticides as their sole purpose in their jobs, or they could be private growers who just handle them for their own property or their own growing crops.

The next group are post-application workers, and these would include scouts or crop advisors, and we assess these for developing early entry restrictions. And we also look at harvesters, or field workers, or people entering fields after the pesticides have been applied. And in this exercise, we would calculate a safe reentry interval for those workers.

When we go into details on the handler assessments -- handler exposures depend upon the formulation of the pesticide. For example, a wettable powder or a liquid would have a different amount of pesticide that is available for exposure to the worker than another one -- say, a granular.

We also look at the activity that's going on with that pesticide -- whether it's being mixed and loaded, or whether it's being applied-- and the amount of pesticide that's handled during a day.

And we also look at the level of protection that that worker is using -- either through personal protection equipment or through engineering controls.

And the way we look at that is that the unit exposure, which is the measure of how much pesticide someone is exposed to per pound of active ingredient that they handle.

And we multiply that by the amount of pesticide they handle during the day, the absorption -- whether it was if we're doing a dermal study or an inhalation assessment. And then we would divide that by the body weight to calculate a dose that that worker would receive.

The data sources that we used to conduct these assessments we obtained from labels. We used that for determining the application rate and the crops that the pesticide is used on.

We try to gather as much use information as we can to know what cultural practices are going on and what is actually is going on in the real world in this situation.

Lacking that, we'll have a set of standard values that we'll use, and these are based on either chemical specific studies that we've seen for other types of chemicals, or other -- based on the judgement of the people doing those assessments.

We would always like chemical-specific studies when we are assessing a particular chemical, and that would be the preferable set of information. And lacking that, we would use information from the pesticide handlers database -- Pesticide Handlers Exposure Database or PHED.

And the next slide would talk a little bit about PHED. This is a database that has been developed by a task force consisting of members from U.S. EPA, from Health Canada, California DPR, and the registrant community represented by the ACPA.

These are actual monitoring data that have been measured, collected. The quality of those data have been assessed, and they have been stored in this database. So, this information is based on actual exposure studies that have been conducted in the field.

It's widely accepted. Right now, it's being used by over 11 countries, and it's our most complete source of pesticide monitoring data. And one of the -- sort of, the benefits in addition to the other benefits of just being a complete source of pesticide monitoring data is that it adds consistency to all of our risk assessments as they go through the Agency.

Now, the question that has always come up is, what sort of numbers are predicted from pesticide handlers exposure data base? So, we looked at an example here. It's a -- using an airblast application on apples at -- of a two-pound active ingredient per gallon. And it's being applied at about a one-pound-per-active -- one-pound-per-acre.

And a mixer-loader -- when they're mixing and loading the pesticide, they would handle about 10 gallons of the formulated product. And based on our exposure numbers from PHED, we would estimate that they're exposed to about three drops of that formulation.

So, the point here is that we're using a system that's using actual data, and we're not predicting that the worker is drenched with the product or the formulation. It's a very small amount of pesticide that they're being exposed to.

The same thing can be done for an applicator in an open cab. If they treat 20 acres per day at 100 gallons per acre, PHED would estimate that they're exposed to about a teaspoon of diluted spray during that eight-hour period.

Just to walk through an example -- Azinphos-methyl -- there's two formulations. There's a wettable powder and an emulsifiable concentrate. It's used on about 50 crops, and it can be applied by four different methods -- air, airblast, groundboom, and handwand.

As you may know, it's acutely toxic by the oral and inhalation routes. And the Agency has determined a short-term NOAEL from a 21-day dermal study in rats that show plasma and RBC cholinesterase inhibition. And the NOAEL is 0.56 milligrams-per-kilogram-per-day.

There is a number of uncertainty factors associated with this. There is a 10-fold factor for extrapolating between rats and humans, and there is a 10-fold factor for variability in humans. The FQPA Safety Factor does not apply to worker assessments, so the target MOE that we're looking for is 100.

Just based on the toxicity of Azinphos-methyl, you can calculate how much of a two-pound per gallon formulation can be absorbed to cause a MOE of less than 100. And for Azinphos-methyl, that works out to be about 1/50th to 1/100th of a drop.

And if you look at closed mixing loading systems as part of the specifications for a dry couple mechanical transfer closed mixing loading system, they can leak about one-tenth of a ml per disconnect.

And if you take that one-tenth of a ml, and if that's absorbed, then calculate the MOE for that worker, it comes out to about 1.6. So, the target MOE would be 100. We would -- if one-tenth of a ml is absorbed, then the MOE is 1.6. So, that's considerably away from what we're looking for.

The next couple slides go through an example of calculating the risk for a handler mixing and loading a 2EC for airblast application. The unit exposures -- we can look in PHED, and based on about 100 replicates of actual studied -- actual monitored data, we would estimate that for every pound that someone handles, they get about 2.9 milligrams on them. And this represents a clothing scenario of a long-sleeved shirt, long pants, and they're using an open pour or mixing system.

So, the next thing to calculate the amount handled per day. If they're using one-pound-per-acre, and they're treating 20 acres per day, they would handle 20 pounds of the active ingredient.

And multiplying that by the unit exposure from PHED, we would estimate that they're exposed to 58 milligrams per day. And then dividing through by their body weight, we would estimate their dose to be 0.83 milligrams per kilogram per day.

And once we compare that to the NOAEL that was selected for the risk assessment for that baseline exposure scenario that we just described, we would estimate an MOE of 0.67 -- and remember that we're looking for a target MOE of 100.

So, this would tell us that just a single layer of clothing without gloves and without a respirator would not be adequate protection for that worker. And we would want to increase the PPE that they're wearing or go to engineering controls. And that would change the amount of pesticide that would -- that they would be exposed to. And when we go through those calculations, the MOEs would be 84. Adding an extra layer of clothing, gloves, and a respirator, and then if we go to a closed system, we would estimate an MOE of over 200.

So, there is our example and sort of a brief description of how the handler worker assessment is done. And right now Tim Leighton is going to talk about the post-application.

MR. LEIGHTON: Okay, thank you, Jonathan. I'm going to go over the section that we're talking about post-application exposure. I hope everybody can hear me all right.

I'm going to go through the process of calculating, basically, REIs, and that's what we do for worker risk when we look at post-application exposure.

Right now, as Kevin had mentioned earlier, the WPS, which is an interim measure, has set REIs based on the -- they're actually based on the acute tox categories.

What we do now through FIFRA and through the RED process is we're going to go and we're going to set REIs based on the actual data that we can collect and based on different types of toxicology data.

First of all, the only thing we can do for post-application to mitigate risk is to set a longer REI, longer duration. And how that mitigates the risk is the residues dissipate over time.

We do not put on more than long pants and long-sleeved shirts for people that are going to go out and do the harvesting. We're not going to expect them to be wearing chemical-resistant gloves or coveralls when they're out in the hot field working for eight hours or more a day. So, all of our assessments when I discuss through here are based on long pants and long-sleeved shirts.

Now, the equation that's up on the board there breaks down how we calculate the dose. And it looks like a very simple equation here, but I've been reviewing these exposure studies for, roughly, 15 years, and believe me, even though you can reduce it to half-a-slide there, there's a lot that goes into this.

And basically, our dose is equal to the DFR, which call the dislodgical foliar residue. And that in itself, there's a lot of data there. We collect dissipation over time.

We have Subdivision K guidelines. They came out initially in 1984, and it discussed how we want to see that data collected. Then we revised those guidelines again in 1991, and we've had them peer reviewed by -- as Jonathan said -- the different countries -- Health Canada, the OECD member countries, and also Health Canada.

Now, to go on with this equation here, then we multiply the DFR times the transfer coefficient. And this transfer coefficient gives us the ratio of the exposure to the residue levels that are out in the field at a particular time.

This transfer coefficient is based on activities, so if we know what a transfer coefficient is for apple harvesting versus something for, say, harvesting lettuce, we can move that from one chemical to another.

So, once we can establish what the transfer coefficient is for a particular activity, then we can take that and multiply it by a chemical specific studies, and we can find out what that dose is going to be.

And then we multiply it by hours worked, and divide it by a body weight. Now, what's not up there right now is the dermal absorption because it didn't fit, but the dermal absorption is definitely a key aspect here.

And it depends on what kind of a tox-study you're going to compare this to. Is it going to be a dermal study, or is it going to be an oral study? And it's definitely a key factor in -- to determine what the risk is going to be.

And the field worker exposure is being driven then by the DFR, which is the amount of residues on the plant leaf, and by the contact rate, particularly on what type of activity. Is it going to be harvesting apples, or is it going to be out cotton scouting. There's a lot of different types of brushing up against the leaves where these residues are.

So, we'll go to the next slide. For the post-application assessment, we have different types of data sources that are available to us. We have chemical-specific studies. And as a reviewer, this is, you know, definitely what I want to see when I'm sitting down to do an assessment.

And what the best thing I could get would be some type of biological monitoring study so you get the true dermal absorption for that particular worker. And to date, though, we're mostly limited to having DFR studies. We do have some transfer coefficients, and we have extrapolated those transfer coefficients to develop what we call our SOP with standard values.

Now, our standard values, we have taken the available transfer coefficients -- either from having a lot of experience reviewing these studies and knowing how much foliar contact you're going to get or actually getting published literature studies where we can cite those data.

And we have come up with, basically, a table of activities. Now, this table is trying to mimic what the ARTF -- and I think there's going to be a presentation later on today. Our table of standard values is trying to mimic what the ARTF is collecting.

We wanted to -- when we developed this table -- make sure we did not underestimate exposure to workers, so we do have, you know, some of our values are probably going to be higher than what actually comes out of the task force. But that was our -- definitely our strategy because we did not want to underestimate the exposure.

Then in 1995, there was a data call-in, and within this data call-in, we have requested dermal exposure for post-application exposures. And what industry has done is put together the agricultural reentry task force.

Now, the data for this ARTF -- it will be coming in, I believe, this fall, and you can hear a little bit more about it from Paula Paul. We certainly were waiting for this data. It's going to answer some of the questions we do have currently. It will be a great research tool to be able to extrapolate the data that we collect there to other situations that we're going to need, and it will also give us use information.

And the use information, which is the next one on there -- right now we currently get our use information from the pesticide labels themselves. That will always stay current. We get information from our other divisions, such as BEAD (phonetic). We have different reviewers getting on the Internet and taking a look to find out what type of ag extensions you can get a hold of -- perhaps the turf growers. I've actually looked and called them myself.

And then we can also look towards USDA. I know they want to get involved more -- not just as reviewer but giving us information that, you know, we're not only looking at the maximum rates, but what is a typical rate on the label?

And that typical rate -- you know, is it used 80 percent of the time, and perhaps that typical rates, you know, a half-a-pound-per-acre, and the max rate on the label is an eight-pound-per-acre, and we can start getting more information that the eight-pound-per-acre rate is only used on some type of infestation, only happens once or twice a year -- maybe every two years. That would still need to be on the label -- we can assess that. And our risk managers at that point will have more information from the risk assessors.

Then the last thing here is the cultural practices. And the cultural practices that we look at would -- to give you an example is how grapes are grown. Some grapes are grown wild without being pruned, a lot of foliage, and a lot of foliage contact. And that's some of our higher exposures.

But if you also -- if you go out into some of the wineries that some people might have seen -- some of the grapes are trestled, and they're pruned back, and there is not that much foliage. And then, therefore, the exposure is going to be a lot less when you're out there picking that.

This is the type of information we're looking for to get a full range of characterizing what the risk would be for one particular crop. There's -- you know, there's a lot of other crops -- tomatoes -- are they grown just lying on the ground, are they staked? There's going to be a lot of difference in the potential exposure there.

The -- and one thing I would like to say here -- it also goes, you know, goes towards the residential market, too, here. The environmental residues -- when you see people publish them, they're not always going to equal exposure.

Just because there's a residue there, you know, you have to bring in the dermal component. What that individually -- they're being a worker or a child -- how are they going to be actually exposed? Are they going to be rolling around on the carpet -- getting out of -- going on a tangent here -- or are they going to be, you know, picking the crop? Are they going to be scouting the crop, or pruning the trees? So, a lot has to do with the human activity, not just environmental residues.

Okay, the next one. And as Jonathan did here, I want to run through a field worker example. And we have AZM up here -- not to pick on AZM, but it was already presented at a public meeting, so we figured that would be a good one to use.

And how we go through an assessment here is we would look at chemical-specific data, which we had for AZM. We had the dislodgical residues that were collected at a one-pound-AI-per-acre rate. And these values gave us residues in micrograms-per-centimeters-squared.

And, basically, I'm not sure how many people here have seen these studies. To do this study, somebody will go out, will apply the pesticide, and then the Day Zero -- about four hours after they have applied it, they go out and do leaf punch samples.

And they would have a little device that takes about a centimeter squared, and they go out, and they just actually do punch and collect them in a jar. Go back, take that jar, dislodge it with some type of a surfactant and just a soap, and get what the residues are.

They will look at that on Day Zero, Day 2, 3, 5, 7, 14, 35, 21, 35. And from there we can develop a dissipation curve and predict the actual residues for each day.

A lot goes into that, also. You know, a lot of these pesticides decay on a first-order kinetics, and you can get a linear extrapolation -- but not all of them. And especially what we've seen with the OPs -- a lot of them are biphasic where the first four to seven days, they quickly dissipate. And then after four to seven days, those residues -- they hang right about the LOQ or, perhaps, above it, and they go out maybe 35 days.

So, we're looking at different methods to be able to accurately assess what that dissipation curve is going to look like.

The second thing for AZM is the chemical-specific exposure study, and I believe this -- I'm not sure if this was done by California or the chemical company itself -- this wasn't mine -- but they did dermal exposure monitoring concurrently with DFR levels.

And, therefore, they were able to calculate a transfer coefficient. And that transfer coefficient is the ratio of the exposure in micrograms-per-hour divided by that DFR level, which is in micrograms-per-centimeter-squared.

And so, you get a transfer coefficient, which is roughly 4,000 here of centimeters-squared-per-hour. And in a concept, you're basically looking at a 4,000-centimeter-squared contact of leaf surface area per hour and getting that type of residue on you.

Well, that's a concept. You're also contacting the fruit itself -- the apples. You're perhaps contacting the bark. So, it's more of a concept of a ratio of the monitored exposure to the residue levels at that time.

Okay, the next one. Now, to go on with this example, the current REI for apples for AZM is 14 days. And the way HED looks at this to calculate what that risk or MOE would be -- we'll take the DFR level -- and as measured it's 1.96 micrograms-per-centimeter-squared on Day 14.

Multiply that by that transfer coefficient, which is that actual human exposure real data -- somebody collecting apples. And we multiply that by an eight-hour workday, and we divide that by the body weight.

And in this instance, our short-term NOAEL is 0.56, and that was from a 21-day dermal rat study. So, we do not need to apply a dermal absorption value. And we take the potential exposure that's actually on your skin -- this is underneath that one layer of clothing, which is long pants, long-sleeved shirt -- and we divide that by that dose, and we get an MOE that's less than one.

So, this would show us at HED based on our tox data -- which is the animal 21-day dermal study, and our uncertainty factors in this case is 100 -- that the Day 14 is not going to be sufficient.

Okay, the next slide. And this is how we -- just basically this is -- I'm picking on AZM for an example -- but this is how we do our assessments generically across the board.

Okay, the next slide we want to discuss the quality of the assessments. Now, this is not entered just for the worker -- the reentry worker, but it's going to cover what Jonathan has gone over as the handlers.

We want to look for consistency of risk assessments between groups. And these groups are -- we try to harmonize with what we do with California, with Health Canada, and OECD.

The exposure method -- exposure methodologies that we have developed through the guidelines -- we have taken them to the SAP in the past. They are being harmonized with all these other groups.

And these groups -- the OECD group is actually taking our guidelines and rewriting them, rewording them to be their own guidelines, and they're very similar. Everybody collects the data the same way.

There is some disparities -- I mean, the way people look at dermal absorption. There is some disparities on what endpoint is being selected, and are you going to use an animal versus a human tox?

But that's more of the risk side of the equation, and what I want to try to focus on is the exposures, and how we collect the exposure data.

The second bullet here is the consistency between results of the model that monitor data. In HED, the scientists -- and I'm sure everywhere else -- that's what we want to do. We want to take data, and we want to -- that we're actually getting a chance to collect, and we want to compare that to our models that we have used in the past or that are currently trying to develop.

And I can -- one of the examples I'm working on the worker exposures for chlorpyrifos right now, and chlorpyrifos has a lot of exposure studies. They have a lot of biomonitoring. There is a lot of worker exposure studies.

And the methodologies used from these guidelines -- the dermal dosimetry being either whole-body dosimetries or patches -- they correlate very well with the biomonitoring collected for the same individuals.

So, we, -- so these -- in this instance -- and it's probably because we have a good dermal absorption value -- that we're able to correlate our modeled areas with what is actually being collected through what's traditionally -- what everybody wants to see is a biomonitoring study.

So, when I see things like that, and it's not the first chemical that I've seen it on -- you know, it gives me a good feeling of where our models are. Sometimes we have to change our models. And the further we go down the line with this data, the better we can make our refinements.

Another example recently is we're looking at aerial mosquito applications. And we have used the spray drift test for -- or the spray drift model, rather -- to look at what the deposition rates would be from this type of an application.

What we had -- maybe two or three weeks ago, James Duke (phonetic) from Florida A & M University come in, and he has been collecting this data down in Florida. And we've been looking -- and we took our modeled results from three or four chemicals we've looked at, compared it to his data that he has actually collected, and they agree very well. We're very happy to see that, actually.

So, that's how we try to go in there -- and our process to develop these models and change the models when they needed to be changed.

The next slide. Another way we look at our exposure and risk estimates is to compare it to monitoring and incident data. And for AZM, California in 1994 looked at peach harvesters. And these peach harvesters show cholinesterase inhibition as the numbers on the slide indicate, which is roughly what our risk assessments show for this post-application.

We're seeing an indication that these people are exposed. That's what our numbers are showing, and they match up pretty well there.

AZM, also in California -- and from '82 to 1990, there was 134 cases reported. The poison control center, overall, from the '85 to '92, there was occupational and non-occupational incidents.

And our -- again, our risk assessments based on the endpoints we use and the uncertainty factors that we use, they are showing that there are some risks, and here there are some incidents' data trying to back that up.

There is also in -- and I just saw this before I came over -- in 1985, 542 handlers were monitored for cholinesterase depression. And out of those 542 for handler --



Now, this last slide here -- this also was presented. This is not new, this was presented before. And when somebody looks at our risk assessments, the first thing they look at it is, why are they different than everybody else?

And right off the bat, a lot of people will point at the exposures. You know, what is HED doing with the exposures? Are they overestimating them, or what's happening here?

If you look here, we're comparing U.S. EPA's estimates to California's. We're looking at apples on Page 14. The dermal exposure -- the third column there -- California had estimated as 0.33 milligrams per kilogram per day.

The Agency -- we have selected a range of 0.24 to 1.88. It falls within the same as California. What we have done in the past is often just put one exposure number out, one risk number. We are trying to bracket that more as a risk assessor because these values -- although we believe they're fairly accurate, you know, the precision is not there. So, we want to give more of a range so the risk managers can make an intelligent decision.

Where the risk come different now, the exposures are the same, same methodologies. Why the risks are so different is if you look at the California -- the first row up there -- they first -- they looked at a rat study, and it was an oral rat study, and they had a 16 percent dermal absorption. Their target MOE was 100. They calculated a MOE of 19. That showed a risk concern.

They have selected -- they have decided to go to the human oral exposure for the tox study. That drops one of those uncertainty factors of 10. Now, we're looking for a target MOE of 10, and they calculated an MOE of 14. That does not show a risk concern.

The Agency -- we have selected a route-specific study. This is not the oral. This is a 21-day dermal, and we always strive for a dermal exposure study when you have a dermal -- a dermal tox study when you have a dermal human exposure problem, which is what it is for reentry workers.

So, we've selected the route-specific study. It's an animal study; and therefore, we shoot for a target MOE of 100. And as of now, with the refinements that have been done so far, that's not where we're at. And I'm not sure how this is set up here, but Jonathan and I are open for questions and discussions.

MS. MULKEY: Well, we hope and expect that you will want to either react to what was done or ask questions about it. But in the interest of, again, trying to have our discussion at the end, we would go ahead with the other presentations. But if there is some sort of narrow, clarifying question that somebody wants to get out on the table now -- Beth?

MS. MARSHALL: What does MOE stand for?

MR. KEANEY: Sorry about that. That's margin of exposure. We used to call it a margin of safety -- MOS. It's the same thing.

MS. MULKEY: And, Shelley, do you have a clarifying questions?

MS. DAVIS: I just have one quick question. On the dislodgeable foliar residue study -- and when I looked at your Azinphos-methyl thing -- and I don't have it in front of me, so I don't have perfect recollection -- it seemed like there were different values -- even, say, within apples, or within cotton, or grapes -- depending on the location.

And I was wondering how you worked that together into your -- the number you put into your equation?

MR. KEANEY: Yeah, that's correct. Our guidelines require -- suggest that people collect data in different areas for apples. We would certainly want to see them in Washington State, which was one of them -- New York State. We usually look for California because it's drier, the residues are going to hang out longer.

And the way we handle that is we will take each site -- generally, we require three of them -- and we will look at them each individually. And if they dissipate similarly, we will combine the three sites. And that's certainly our goal, and it's great if it works out that way. It doesn't always work out that way.

And in the future -- what we do now, we look at if one is a standout as the worst one, that's the one, usually, we're going to end up looking at for the label. In the future, perhaps, when the ARTF data comes in, maybe we're going to have to look at regional geographic REIs. It's going to be difficult to say until we see the data.

MS. MULKEY: All right. Yes, Bill.

BILL: I just want to ask another clarifying question. The difference in the Cal DPR use of oral human data, and then EPA's. Does it consider those data, or why was California considering those and getting an acceptable MOE, and then you guys weren't? I'm just wondering what the --

MR. KEANEY: That -- is that -- I think that's more of a -- the policy of using human studies versus the animal study. Is that --

MS. MULKEY: Well, there are two things going on here. One, Tim explained, which is the preference for a study involving the dermal root of exposure.


BILL: Right.

MS. MULKEY: As opposed to the oral roots. So, that's one of the things that's going on here. The other, more complicated question has to do with the use of these human toxicity studies. And I'm willing to answer the question about what the policy is, and what the status of our policy is, but we -- give me a pass on doing that right now, and we can come back to it later, so you can keep --

BILL: Sure. Can we get to that, though?

MS. MULKEY: We can, yeah, I'll try to explain what the status of that is before the day is over.

BILL: Oh, okay, great.

MS. MULKEY: Remind me.

BILL: Okay.

MS. MULKEY: Okay. Shall we move now to our guest presentations? These, of course, are the views of the presenters and not those of the Agency. But Nelson has something to offer, and then Paula, I think, is going to present some of the work that industry -- (inaudible).

Have we distributed your material? Is it part of the packet? Good.

MR. CARRASQUILLO: Yeah. Believe me, I'm happy to be able to -- (inaudible) -- this presentation. (Inaudible) -- some confusion about whether -- (inaudible) -- the Farm Worker Protection Standard -- (inaudible) -- our nation's farm workers. (Inaudible) --

MS. MULKEY: Try to get him a mike.

UNIDENTIFIED MALE: Can you hear back there, or no?

MS. MULKEY: Oh, that's -- that will probably work.

MR. CARRASQUILLO: Okay. The Farm Worker Health and Safety Institute is a unique consortium of three community-based farm worker organizations. They are part of the Farm workers Support Committee and based in New Jersey, the Farm Worker Association of Florida -- (inaudible) -- union of farm workers in -- based in El Paso, Texas.

Before I continue, I would like to make a statement in relation to the deaths of two farm workers a couple of weeks ago in New Jersey. They died because of heat exposure working under record temperatures of 100-plus degrees. And they died after leaving the fields and going to the camp.

As of this moment, the forensic data that is available is about heat exposure. We are looking into that based on the supposition that it's the farmer's responsibility to have ordered those workers out of the fields once the temperature went up to higher levels.

The background, no? The study that we did is based on the Worker Protection Standard as implemented in 1995. We did it based on a -- what we called the Diagnostico. The Diagnostico or Diagnostic Evaluation is a questionnaire developed by the Farm Workers Support Group to assess the living and working conditions of farm workers.

The Diagnostico represents information collected for a specific farm labor camp, farm company, or work group, and no data from an individual farm worker.

Questions include topics related to hour and wage, pesticides and the WPS, field sanitation, housing, and farm worker health.

This study focuses specifically on the pesticides and the WPS section. The Diagnostico was administered in Spanish by current and former farm workers from CATA and the Association.

During the three years, staff from CATA and the Association visited different farm operations where they administered the Diagnostico. Four-hundred-eighty farm operations were surveyed where approximately 20,000 farm workers were employed.

These farms covered various agricultural industries, such as fruits, vegetables, nurseries, farms, or a combination of those.

Two-hundred-thirty-two Diagnosticos were administered in seven counties in southern New Jersey. Two-hundred-forty-eight Diagnosticos were administered in ten counties in northern, central, and southern Florida.

Data collection and analysis. Staff from CATA and the Association were trained in interviewing techniques and in the Diagnostico tool.

The Diagnostico was conducted over several visits in order to obtain the information. The Diagnostico represents data obtained from a particular farm, not a particular farm worker.

Data recorded on the Diagnostico formed the basis for the analysis. Data for New Jersey and Florida were analyzed separately; and therefore, percentages in the results section was not accurate to 100 percent.

Two-hundred-thirty-two Diagnosticos were administered in New Jersey, and 248 in Florida, for a total of 480 Diagnosticos. Only valid cases, yes-and-no responses were analyzed.

The result. This is only a summary of -- or highlight of some of the main findings from this study. Due to time constraint, it is not possible to present all the results. For further information, you can contact the Office of Pesticide Programs, where there is a copy of this report on file.

Questions were separated into two categories -- questions related to prevention activities, and questions related to possible exposure. These results represent the farm operations that were surveyed for this study.

So, prevention activities. Does the employer inform farm workers of the different pesticides used in the area where they worked? Thirty-five-point-one percent of employers in New Jersey -- in terms of number 78 -- informed their workers; 24.8 of employers in Florida -- numbers of 56 -- informed their workers.

Does the employer provide written information on pesticides? Thirty-five-point-three of employers, or 79, provided written information in New Jersey. Twenty-four-point-six of employers provided written information in Florida.

Does the employer provide farm workers' pesticide safety training? Thirty-five-point-four of farm workers receive a training in New Jersey; 54.5 of farm workers receive a training in Florida.

Does the employer inform farm workers about the reentry interval after an area has been sprayed? Forty-eight-point-six of employers informed workers about the reentry interval in New Jersey; 39.7 of employers informed workers about the reentry in Florida.

Does the employer provide a sink for farm workers to wash their hands? Twenty-point-four of employers provided a sink in New Jersey; 48.7 of employers provided a sink in Florida.

Exposure. Have farm workers reported being sprayed with pesticides after -- either directly or indirectly? At 5.4 of the farm operations surveyed in New Jersey, farm workers report that being sprayed with pesticides. At 42.7 of the farm operations surveyed in Florida, 97 farm workers report that being sprayed with pesticides.

Have farm workers reported working in an area still wet with pesticides? At 6.6 of the farm operations in New Jersey, 14 of them, farm workers reported working in an area wet with pesticides; 51.4 of the farm operations surveyed in Florida, or 113, farm workers reported working in an area wet with pesticides.

Are pesticides stored at camp or farm surroundings? At 13.3 of the farm operations surveyed in New Jersey, 30 of them, farm workers report that there were improper storage of pesticides. At 22 percent of the farm operations surveyed in Florida, 24 of them, farm workers reported that there was improper storage of pesticides.

On this information, and data, and others in terms of the study, conclusions based on the farms operation survey -- based on this, we are saying approximately one in three farmers in New Jersey, and one in four farmers in Florida are informing farm workers about the different pesticides used at the work site.

Approximately one in three farmers in New Jersey, and one in four farmers in Florida are providing farm workers with information on pesticides.

Approximately one in three farmers in New Jersey, and one in two farmers in Florida are providing farm workers with pesticides training.

Approximately one in two farmers in New Jersey, and less than 40 percent -- or two in five farmers in Florida -- inform farm workers about the reentry interval.

Number five, approximately one in five farmers in New Jersey, and one in two farmers in Florida provide farm workers with a sink to wash their hands.

Based on this, we can conclude that the confines of the WPS as it relates to questions on the prevention activities is below a 50 percent level of compliance.

This level of compliance to us -- to the Farm Worker Health and Safety Institute and the farm workers organizations that compose it -- this level of compliance -- about four years of the -- after four years of the WPS is low and unacceptable. And as a result, the WPS is not protecting the nation's farm workers.

MS. MULKEY: Thank you very much. Do we have any clarifying questions? We will have an opportunity for this to be included in the discussion. If you could hold -- yeah.

UNIDENTIFIED MALE: Will you stand? Okay.

MS. MULKEY: If you want to maybe put it in writing, and if it's a clarification, we can maybe arrange to get it during our discussion. Jose, you had a clarifying question?

MR. AMADOR: Nelson, have the local agricultural agency was involved in this so -- (inaudible) -- did they -- they were --

MR. CARRASQUILLO: No, this was done by a staff from CATA in New Jersey and staff from the Association. Of Florida -- in Florida, obviously. This was done --

MR. AMADOR: But have they seen the result of this information, or how did they reply because this --

MR. CARRASQUILLO: This is the first time -- the first time that we have actually presented the story. We have provided the story to the Office of Pesticides Program, but this is the first time that we are making it public.

MR. AMADOR: So, they haven't had a chance to see the information or -- (inaudible).

MR. CARRASQUILLO: No, no. This is the first time this group has received it.

MS. MULKEY: Okay, George, do you have a --

MR. PAVLOU: Thank you, Marcia. I think surveys are good, and I think we should encourage their use, and we should applaud the use of more surveys because, you know, from my perspective as a manager, you know, it's a good tool to use to help us concentrate in terms of, you know, what areas we want to focus our activities.

At the same time, surveys can give you good news and bad news. You know, in this case, I think from the exposure perspective, the goods may be -- I mean, the news may be viewed as good because it shows more than 90 percent compliance rate in terms of exposure. But at the same time, we --

MS. MULKEY: George, I'm sorry, I -- now that Jacqueline has interrupted you, I'm going to. If you want to discuss this -- I do -- we do want to encourage that, but we do have one more presentation. So, if you have a clarifying question now --

MR. PAVLOU: (Inaudible) -- only questions?

MS. MULKEY: Right, and then we're going to have a discussion. We've got a nice, long period left, and we --

MR. PAVLOU: Okay. With the -- when the workers were responding, was that from one farm or, you know, there were workers from different farms who were responding to your survey?

MR. CARRASQUILLO: No, the survey was administered through a period of years. What we called the Diagnostico -- each Diagnostico represents a farm or a camp in which workers live. It might be that during the period of years, those workers changed from one year to the other, no?

So, instead of focusing in terms of specific workers, we focused the answers in terms of the camp or farm operation -- (inaudible).

MS. MULKEY: So, the n where you showed the number -- like, the n for each question, that was farms or camps?

MR. CARRASQUILLO: Right. It's not one worker, it's just not one worker.

MS. MULKEY: So, like -- not one worker, it's one farm. He said there was a total of 20,000 workers involved, as I understood the presentation. Any other -- just clarifying questions? Paula.

MS. PAUL: Just a clarifying question. Farm workers in -- I guess, a majority of them, I guess, work in camps where they will go from farm to farm -- maybe harvesters I'm thinking of anyway. Like in California, they kind of go south to north.

How did the survey deal with the fact that they may have had several employers? Of course, maybe that's California, you were in Texas.

MR. CARRASQUILLO: Yes. Because it is not focused in terms of the farm workers, it's focused in terms of the farm operation that has been -- the Diagnostico has been about.

MS. MULKEY: (Inaudible).

UNIDENTIFIED MALE: Perhaps your answer -- I'm trying to also clarify if 20,000 workers, you know, and you chose about 500 people to study -- and is this randomly picked or does this 250 people at each farm that you just followed all along?

MR. CARRASQUILLO: No, no. It is not randomly picked in the sense that it is based on the geographical areas, the specifics to where the organizations are working, and the farms operation in that area.

So, for example, in New Jersey, we work in the southern part of the state. So, the camps and the farms to us is equal, no? We visited those camps during the -- let's say, three years, and during the season, several times.


JAY: As you did the data collection, what if there was disagreement amongst the workers at one farm as to the answer of the question? If some said yes, and some said no, how was that compiled?

MR. CARRASQUILLO: Right. Yeah. In circumstances in which there was a, like, a discrepancy in terms of testimony, we tried to visit again. So, that's why the data represents not a specific moment in time, but a period of time. All of them within three years, basically.

So, in order for us to try to get to the -- to avoid interpretations, but to get to the bottom line.

MS. MULKEY: All right. Well, thank you. Paula.

MS. PAUL: Okay. Can everyone hear me? My name is Paula Paul, and one of the hats I wear beside sitting on the Pesticide Program Dialogue Committee, is I also chair the administrative committee of the Agricultural Reentry Task Force. So, this appeared to be a nice opportunity to share the activities of the task force, and what we've done, and where we're going.

And I want to thank the people at EPA because when I was thinking about this, and given the complexities of how you do a worker safety analysis, I would like to thank the people at EPA for providing that information because I was thinking, how are we really going to talk about this without a baseline of, really, what the data are and how they're used?

My talk is going to focus on the part here that's highlighted in green on post-application and reentry. As the speakers from EPA said, the applicator, mixer-loader, and equipment cleaner are dealt with through the pesticide handlers database.

And I would also like to compliment Tim Leighton. He's a fairly modest young man, but, really, Tim was instrumental in working with the industry in his previous life with Versar (phonetic) at developing the pesticide handlers database.

I also want to emphasize that worker safety is an issue that our industry takes very, very seriously and has for some time. We've been working for over 10 years, beginning with Peahead (phonetic), working with the EPA, California, and Canadian authorities to try to improve the base of data that's available for the regulators to make worker risk assessments, and the industry, for that matter.

And evidence of that is when we were developing Peahead, one of the main issues was how we deal with data compensation for the studies that are being incorporated into the database.

And we had almost 100 percent agreement within the industry that companies, when they submitted their studies, waived their rights to data compensation for inclusion of the studies in the database because we wanted to make it available easily for the Agency in developing these data.

As the PHED project was winding down, and there is still, I think, is some opportunity to add to that database. But we also recognized that there was room for improvement in the database that dealt with post-application exposure.

And there was a long history beginning with the spray drift task force of taking a task force approach to this when data are, what we call, generic. And as Tim pointed out, the transfer coefficient data are not product-related. They're activity-based.

And so, the job of the Agri-Entry Task Force is to develop a database of transfer coefficients to deal with this. And I think Tim has covered this adequately, but the data you need for a reentry risk assessment, you need reliable toxicity data. And the variability often occurs when you have different levels of data, or different types, whether using dermal or oral data.

If you don't have dermal data, you need that dermal absorption data. You need product-specific data on foliar residues, as was pointed out. And then you also need to have a good idea of what the contact potential is going to be, and that is what we're working on in the task force.

I would also like to point out that the work of the task force or the organization of the task force preceded the data call-in. We actually came together as a industry at the -- through discussions with EPA, California, and Canada. We recognized this needed to be done, and the Agency was helping us in terms of data protection.

We decided it would be best to do this and encouraging all of the industry to participate if we could do it under a data call-in.

The objective of the ARTF was to first identify the scope of agricultural reentry activities. There wasn't actually a good resource that identified all of the crops and all of the reentry activities that occur in crops.

So, with the first undertaking before we began to think about doing any studies was to do a survey of growers and extension service to ask them what crops are grown -- and within those crops, what kinds of reentry activities occur? When they occur, how long, you know, how much time is spent? And we call this the scope survey.

And it was to give us a handle and also to give us an idea of what kind of contact those activities -- occur during those activities? If it's a tall crop, if it's a low crop, if it's a harvesting activity, what parts of the body are exposed? If it's a low crop, it may just be, you know, the lower legs or -- but if it's a tall crop, it could be the entire torso, and arms, hands, whatever.

So, it's not just harvesting, but there's irrigation activities, weeding, anything that occurs.

And once that was developed, then we were going to develop a strategy for developing a database of generic transfer coefficients to cover the scope of agricultural activities.

In terms of the Ag Reentry Task Force, we have 28 member companies. They represent the -- all of the basic producers, including companies that produce generic brands of the products who are basic registrants.

We allocated a budget of $23 million to the -- and this points out one of the values of task forces. When you're undertaking a big project like this within a single company, it would be very difficult to generate $28 million for a project.

But this allows us to take a more global view and to put together a really -- a working database, something that's really going to be valuable to the regulators.

As I mentioned, we -- the first activity was to identify the scope of reentry activities and to group them by exposure potential just based on survey information.

And once that was accomplished, we also undertook to collect all of the existing data, and we then review -- we purchased all of the data that were going to be useful to the project from the member companies. We evaluated it, and then once we looked at it, we could begin to identify where the data gaps were and plan new studies.

And we're -- at the moment, we're in the process -- we have been for the last two years -- of generating additional data, and this will continue for another couple of years.

And we're, also, at the same time building a database, which is easier said than done we're learning. And we'll populate that database with the information that we gain from the existing studies and the new studies that we are developing.

In terms of our time line, just that the task force was formally established in 1995 after the data call-in was issued. However, the task force was preliminarily organized even before that in 1994 when we recognized the need for the data, and it was sort of -- the working with EPA.

You know, I'm wondering if I missed a -- no, no I've got it here. We -- actually, we purchased nine studies -- that's a mistake, you might want to correct it in your overhead -- in 1998 after reviewing the existing data, we purchased nine studies.

We completed the scope survey at the end of 1998 and submitted that to EPA in January of 1999. And in that, we identified over 1,000 -- it was something, I think, 1,143 reentry activities based on crop and reentry activities for crops.

And we consolidated those based on the contact information we had into what we call 14 clusters. And those 14 clusters go from what we believe are high activity -- high-exposure activities to low-exposure activities.

And as we populate the database, we'll be confirming whether this thesis was correct and making adjustments as necessary. But so far, as we've looked at the data, you know, with some minor adjustments, I think we believe this is a reasonably accurate way to estimate the contact potential.

This November, we have a deadline that we are working very diligently toward, and it's not an easy thing. I think Tim did a very nice job pointing out that just doing these studies, it's not a small thing.

Before you go out to the field and actually do the exposure study, you have to do quite a number of preliminary studies to look at the stability of the chemical. You have to choose a chemical that you can analyze. You have to look at the stability on various matrices that are going to be used. And there's quite a bit of analytical preparation that goes along with actually doing the study.

And this November we will be submitting 14 studies. I believe nine of those are reentry studies, and nine of them are the preliminary data that form the basis of our studies.

We're concentrated initially on the high-exposure clusters because those were probably -- we considered that to be the first priority.

And we're continuing to work, and every year, every November, we're going to collect the studies that were done the year before, and we will submit those to the Agency. So, we are now beginning to work through a process of how those studies will be reviewed, and, you know, confirm that the data are adequate to put into the database.

And the current plan -- although this is subject to adjustment -- is to try to complete by 2001 -- complete all of our research and complete our database, populate our database, and make that available to the Agency.

Depending on the results, I suppose -- I think we'll still have the database completed, but we may find that there may be a few studies or bits of information as we learn more.

Just in summary, some other aspects of how the task force operates. We have regular oversight and input from regulatory experts at EPA, the Canadian PMRA, and the California Department of Pesticide Regulation -- CDPR, excuse me -- that we find very valuable because as they are the people on -- people like Tim and Jonathan.

They are people who are doing the actual assessments -- are helpful in reflecting back to us what their needs are because we want to make sure that the data we provide are going to be useful to the regulators. They also have a more global view in that they see all the compounds and understand the issues from a different perspective.

At the same time, companies are developing product-specific data under the data call-in. They're developing the foliar residue data that is specific to their formulation and any other data -- toxicity data -- that might be necessary to do a reliable risk assessment.

And just -- I think Tim also mentioned this -- but when the Agency did their SOP, they wanted to make sure that the transfer coefficients -- that they were high enough to not underestimate risk. And, indeed, we are finding from the preliminary data that we have that they are conservative.

And the other value in the activities of the task force is, I think, as an industry, we are improving our overall expertise on worker exposure and worker protection.

Every time we do a study, we videotape it. A number of the company experts in worker safety are able to visit the sites. And every time we learn something that we didn't know about how farm workers work, how the farm industry operates, and things that I -- we hope will be helpful in translating into ideas that can improve the compliance and safety to workers.

I think that's all I have. Thank you.

MS. MULKEY: Thank you very much, Paula. Again, do we have clarifying questions?



MR. AMADOR: Paula, the report that you bought -- you say you bought eight studies -- purchases?

MS. PAUL: Mm-hmm.

MR. AMADOR: What kind of studies are those? I mean, who do you purchase it from, and what are they comprised of?

MS. PAUL: Okay. These -- I probably don't need this because I have a booming voice, but -- this is a list of the studies. The ones in bold are the ones that the task force has -- will be submitting this November. The ones that aren't bolded are the ones we purchased, and they were purchased from registrants.

I think one of them was the Azinphos-methyl study in apples, actually. And a number of the registrants had individually, based on their own chemistry, seen the need for reentry studies and conducted them under the normal registration process.

One thing you can't do as a company is to take a look at all of the -- you know, all of the activities because some of those may not be relevant to your particular product line. So, the value of taking everything into the task force is that now we can take a more global view, take a look at all of the activities.

So, it's taking all of the data that EPA had in their data. And we also considered published data, but at least at the moment, because often published data -- California have a good database, for example -- but published data, we don't have access to the GLP compliance and the raw data that underlines the study sometimes.

So, we had to set up a set of quality criteria for the studies that we were putting into the database. And it had to with GLPs, it had to do with analytical aspects of how the study was conducted. So, we wanted to make sure that it was a high-quality database.

MS. MULKEY: The reason I'm still limiting this to clarifying questions, and we need to talk about when we want to take our break, and how we want to -- so, clarifying questions? Carolyn.

MS. BRICKEY: Yeah, I was just wondering since you have two more years to complete your database, if you have, or will consider, interviewing workers -- surveying workers?

MS. PAUL: Well, that isn't in our plan right now. I'm just trying to think -- you see, our focus is developing this database of transfer coefficients.

I think the work that Nelson did in his is very valuable. It's something that should be considered, but I'm not sure that it's within the scope of what the Ag Reentry Task Force is -- has identified, at least at the moment.

MS. MULKEY: Okay. Sheldon.

MR. WAGNER: I would like to ask Paula, you are calculating those, then, based upon your concepts of transfer coefficient and dislodgeable foliar residue. Is that what you're doing?

MS. PAUL: Mm-hmm.

MS. MULKEY: And Shelley.

MS. DAVIS: I got a couple quick questions. In terms of the transfer coefficient aspect, are you finding that there is consistency between different products, or is there -- what is the level of variability?

MS. PAUL: Well, as Tim pointed out, a transfer coefficient is at activity-based. This is where this is a very -- even people in the task force -- some people in the task force don't really understand this. But the transfer coefficient is activity-based.

I think of it sometimes as the amount of contact the skin has a potential to have with, let's say, the foliage. So, it's not related to the product.

When you do your risk assessment, you look at the residues, the dislodgeable residues, and that's where you bring the product specific piece into the risk assessment.

MS. DAVIS: Well, that's what I'm really asking. I understand what you're saying, and my question is, have you really found that, say, you know, something that started out as a powder, or something that started out as liquid, that it really does transfer to the same extent, whether it's fat-soluble or water-soluble. I mean, I don't know what would go into it, but --

MS. PAUL: There are products -- oh, there are product differences in transfer. I can speak from our company point-of-view that there will be -- there are often differences between an emulsifiable concentrate and a wettable powder, for example.

That's why when you're doing a dislodgical foliar residue study you do it with the formulation that's actually sold because that does have an impact on the dislodgical foliar residue.

MS. DAVIS: But in terms of the amount that's considered the transfer coefficient, it isn't -- it isn't a factor?

MS. PAUL: No, the factor is how -- is what is the potential for the skin to contact that surface -- whether it's foliage?

MS. DAVIS: I see. I see.

MS. PAUL: Yeah.

MS. MULKEY: Well, thank you, thank you.

UNIDENTIFIED FEMALE: Marcia, I have a single question.


UNIDENTIFIED FEMALE: Paula, will your database and the underlying data be available to the public?

MS. PAUL: I knew that question -- I was waiting for that, and I thought, how will we answer? Of course, it will because any data that registrants submit to the Agency is available.

It will -- the only limitation is for registrants using the data to support a registration. And we will be very strict with companies who have not contributed to the development of this database using the data to support their registrations.

But in terms of other people -- whether it's farm worker organizations or, you know, we are going to look forward to working with the broad spectrum of people and the data -- any data submitted to the Agency is available, so that shouldn't be --

MS. DAVIS: Marcia --

MS. MULKEY: Yes, Shelley, do you still have another clarifying question?

MS. DAVIS: Just one other quick question. In terms of the studies that you did -- that you all did -- are -- were these real-world conditions, or was this like a test site?

MS. PAUL: No, these are real-world conditions, and the workers are real farm workers. And, in fact, we're just dealing with an issue of -- because we're doing a study in horticultural -- where they employ a lot of women. And we've had an enormous discussion on, you know, what, if there's anything special you need to consider when you're studying women.

But we have concluded that if there's, you know, if women are the primary work force, that we have to study women.

MS. MULKEY: All right. We have almost a full hour left in our schedule for discussion. We also have been here awhile. If you prefer to take your break now and come back for discussion, we're game with one caveat. If you take more than the 10-minute break scheduled, we're not going to have a full hour for discussion.

And my sense is there is a lot of interest in discussing this -- all of the things that -- so, let's really limit ourselves to 10 minutes, which by our calculation means that at a quarter until we're all back in our seats, please. And this time, I really mean it.



MS. MULKEY: We'll go ahead and get started. Well, Ken, you started us off on a thoughtful note in our first session, so, see what you can do for us this time. MR. ROSENBAUM: Okay. Well, a couple of observations and then a question. First of all, blending in some things from yesterday, it struck me this morning that in terms of the budget and the -- of the Agency, if we instituted a fee-per-use for acronyms, we could forget the fee-for-service.

And a little back of the envelope calculation this morning showed me that about 25 cents per acronym, written and spoken, we could have had coffee and juice at the break.

A second observation -- maybe tie into something that we'll talk about at the end of the meeting this morning, Nelson's presentation brought up the importance of thinking about enforcement issues.

And one of those suggestions I think we talked about when we met at the beginning of the year was bringing in someone from the Office of Enforcement and Compliance Assistance to sit on the committee. And that would have been a very useful person to have on the committee today, so reinforce the thought that that might be --

MS. MULKEY: Well, a point well made. And we probably did not follow through on that as well as we might have, so --

MR. ROSENBAUM: There's still time.

MS. MULKEY: We did invite them, but we'll try to do a little -- we'll try to cajole, and arm-twist, and a few of the other things that we know how to do to have our colleagues with us.

MR. ROSENBAUM: Okay. Then --

MS. MULKEY: Well, someone is here from that office -- a -- (inaudible).

MR. ROSENBAUM: Make them sit at the table. MS. MULKEY: Is that right? You want to identify yourself, just so folks will -- okay, they have always been pretty good about attending. But I know your suggestion was to sit at the table, and I think we need to heed that.

MR. ROSENBAUM: Let me ask kind of a rookie question -- a science question. I address to Tim and Jonathan, and I started talking about it with Paula, as well.

It's my observation that scientists tend to be trained to look at the mean, and lawyers are trained to look at the outliers. And when I heard the presentation this morning about exposure and about looking at mean exposure, what struck me was, well, that's interesting, but what we're really concerned about is protecting the whole population.

And, therefore, it's very important to know the variation and to know the extremes. And I wonder if that figures into the standard setting?

UNIDENTIFIED MALE: Yeah. Our assessments as we're getting more and more data are starting to give more of a full range of what we believe the exposure and, therefore, the risks are going to be.

If you look at central tendencies, have we done it in the past? And if you look -- if you take an essential average or mean level for an exposure, you put that with a maximum or a bounding rate on an application rate, and perhaps the maximum value you're going to find for the DFR levels -- that dislodgical foliar residues -- I saved myself a quarter there.

But if you can mix and match these different variables, you can get central tendencies and upper bounds. And you can come out with a high-end exposure, and oftentimes, it might be above what your maximum actually is.

And we can see that more when we get some of this data, and you can start doing Monte Carlo assessments. And I think you'll find when we put together what we believe to be a high-end exposure, you know, we're truly not underestimating. And we're also trying -- we're trying to avoid getting over that hundredth percentile.

MR. ROSENBAUM: Okay. Another quick question, then I'll pass on -- pass to the next person. You mentioned a little bit in your presentation that you looked at some monitoring and instant data -- or that some monitoring and instant data had been collected.

Have you ever tried to test your models -- your exposure models by predicting what that monitoring and instant data ought to be and then seeing how close your predictions are to the actual data?

UNIDENTIFIED MALE: For the incident data, you know, especially, if we're looking at OPs now, and we're starting to look at plasma, RBC, connoisseur's inhibition, and we're regulating on a NOAEL level -- a no-effect level -- plus an uncertainty factor -- our assessments if our MOEs are below that if you're looking for that magic factor of 100, you're not going to always predict that you can find some type of incident within somebody.

MR. ROSENBAUM: Have you ever then --

UNIDENTIFIED MALE: And that goes back on the sensitivity of the endpoint that was --

MR. ROSENBAUM: Have you ever then thought about doing some sort of monitoring that you should be able to predict? In other words, devising a test to test models?

UNIDENTIFIED MALE: Well, I'm going to have to back out here a little bit, but we do have a group of people that do incident monitoring within AGD. And I'm not as familiar with their work as I should be, but I think we would have to probably go towards that.

UNIDENTIFIED MALE: Yeah, I could answer -- maybe add a little bit to that. When you look at the exposures based on the incident data, it's very hard to know what their real exposure to that individual was because it's, sort of, -- you see the effect, but then you want to go back and try to trace what that exposure that produced that effect was.


UNIDENTIFIED MALE: Well, there's no evidence that you can really collect or analyze them. So, it's hard to do it if you're, sort of, looking after the fact.

UNIDENTIFIED MALE: Oh, dear. I mean, but what we're really concerned in is real world effects.


UNIDENTIFIED MALE: And so, what you're -- what it almost sounds like -- and I hope it doesn't sound -- it isn't true is that your methodology is so disconnected from the real world that you really can't tell us about real world effects.

UNIDENTIFIED MALE: I don't know if I would put it that way.

UNIDENTIFIED FEMALE: Yeah, I think the level at which we're currently using biomonitoring and incidents data is such that we're trying to confirm -- it's more of a yes, no. We know that at a certain point in our risk assessment, we expect to begin to see an effect taking place.

And our use of current monitoring data -- (inaudible) -- data, just to see whether or not we're beginning to see a, sort of, a response.

For instance, cholinesterase depression in workers in California occurs not at levels, perhaps, that are considered to be terribly adverse in the sense of that the people are ill, but that the sense that they're showing they have been exposed. They are being exposed at rates which we consider to be consistent with our risk assessments.

So, we view that sort of a confirmation as being terribly important for us. I think that was the point of one of the slides in here.

We're also looking at studies -- we're looking at things like in-haze, which are less specific, certainly, but give us a sense of chronic assessments. At health -- the agricultural health study is also looking at some biomonitoring to try to determine the level of exposure in farmers where they -- farmers where they have records of how those people are exposed.

We are not commissioning at this time, though, specific biomonitoring studies where people are exposed to a given level and then monitored.

But to the extent that we have incident data and biomonitoring available from -- (inaudible) -- data, we are using that for confirmation.

MS. MULKEY: Thank you. Beth.

MS. MARSHALL: Well, I would say Nelson brought us pretty abruptly down from 30,000 feet this morning. My question is, I would like to find out a little bit more how the Worker Protection Standard is enforced. Is there anyone who can tell us that here?

MS. MULKEY: Kevin, you want to take a crack at that? Maybe I can supplement it. And George may want to add something, too.

MR. KEANEY: The federal pesticide programs that delegated for enforcement to the state levels, so in this case, it would be enforcement out of a state agency. And the agencies are usually agricultural departments -- some cases, environmental protection departments.

MS. MARSHALL: What kind of -- what kind of monitoring, if any, does EPA do to find out if the states are, in fact, enforcing?

MR. KEANEY: There are grants. I might ask, perhaps, Micky Post (phonetic) to speak in more detail about it from enforcement. But we are in a grant relationship with the state agencies for enforcement, and so there are -- there is a reporting back on the types of inspections that are done.

The incidents that, you know, the results of the inspections, and the follow-up on the inspections. That's all part of the grant reporting process, so we would have access to that, sort of, state data.

MS. MARSHALL: What kinds of grants do you give to the states for enforcement? Did you say -- you did say grant?

MR. KEANEY: There are -- yes, there is grant money that goes to the states to support -- to help support their enforcement efforts, yes.

UNIDENTIFIED MALE: Can I supplement?


MR. PAVLOU: Yeah. We have two kinds of grants. You know, for the State of New Jersey, essentially, we are providing them -- what we call a program-added grant, in terms of managing the pesticides program. At the same time, we are providing them with funding to enforce the portion of that program.

Last year, we gave them about $200,000 for the program -- (inaudible) -- and about 200,000 -- $266,000 for the enforcement element -- all of it. Last year, they conducted about 185 inspections with respect to workers' performance -- protection, rather.

Their performance is not that bad. I mean, I'm not condoning the numbers, you know, as a result of the survey that Nelson, you know, provided to us. But New Jersey is probably on the high end in terms of running a very competent, you know, program.

They have their own worker protection standards that they developed in 1996. For the first two years, though, they concentrated in terms of compliance assistance to go out to the farmers to help explain to them what their responsibilities were.

Last year, they began concentrating on the enforcement end of it, as well. So, and as part of our performance management agreements that we're having with New Jersey, we do provide oversight in terms of their delivering the outputs and the outcomes that are specified in those grants. And they have met those responsibilities, you know, in terms of qualitative and quantitative, you know, outcomes.

New Jersey also produced, you know, safety booklets. I think, you know, right now they have about, you know, safety booklets in terms of compliance assistance, in terms of eight languages. They're going to increase that to 10, as well, during the upcoming year.

They're going to be conducting their own surveys, as well, next year as part of our grant. But worker training is something that is a little difficult to oversee.

One, it has to do with the language barrier. Two, it has to do with the reluctance of workers to step forward and say, you know, this employer of mine is not really providing adequate training, adequate safety for fear that they may lose, you know, their jobs.

But, you know, as I was going to, you know, say previously, I mean, that's something that, you know, we can use the survey to meet with New Jersey, and, you know, evaluate -- not evaluate the results, but at least use the results to help us concentrate in areas that we need to improve.

MS. MULKEY: You -- this area of enforcement and compliance, and the role it plays in following labels is a difficult one in the pesticide program in all contexts.

But on-farm enforcement has always been a special challenge, and I think it's worthy of more attention. And if this group is interested in more attention to that set of issues, I think we're receptive to trying to get the benefit of your perspective on that. In fact, the next couple of people I'm going to call on probably have some sense of some of those challenges from the point of view of the conduct of agriculture. And so, staying with just going around, we'll go to Jose.

MS. LINDSAY: Marcia, just on the enforcement -- a question.

MS. MULKEY: Oh, Anne wanted to complete an answer, I'm sorry.

MS. LINDSAY: Just a minor addition. We've -- this year -- just in the last couple of months -- had some preliminary discussions with the Department of Labor with regard to enforcement because they have their own set of agricultural standards that they're responsible for enforcing and feel that they have some particular expertise in the area that we at EPA and the pesticide program might benefit from.

And I can say from our initial discussion with them, I'm pretty sure that we've got some things that we can benefit. So, this will be part of the whole -- the overall reassessment that we're doing is, sort of, looking at how we can use all the tools we've got, including forming some new relationships and partnerships that I don't think we've developed as well as we might have.

MS. MULKEY: Okay, Jose.

MR. AMADOR: I think that's a good comment, Anne, because I know at least in the Lower Rio Grande Valley the Department of Labor is being very involved in looking at the labor of minors and the complications that they have with minors that comes to the field to accompany the parents.

I had a couple of questions for Nelson. Nelson, on Page 5, when you talk about the sink, does that mean a place for them to wash their hands out in the field? That was the question?


MR. AMADOR: And the Lower Rio Grande Valley, at least, the farm is obligated to have some kind of a toilet facility. And usually on that facility, there is a place with water and soap for the farm workers to wash their hands.

This is an implication this is not being followed in 50 percent of the cases?

MR. CARRASQUILLO: Mm-hmm. Right. It's a regulatory measure. You have to have handwashing facilities available to workers.

MR. AMADOR: And according to survey, 50 percent of the people that they interviewed did not have the facilities?


UNIDENTIFIED MALE: And I'm surprised to see the figure that high because I know at least of the people that I work with this is -- almost everybody has in the field some of these trailers, so they move around from field to fields with both the toilet facility and thing attached to it, so it has some facility for wash their hands.

So, I'm surprised to see the figure being that high. I mean, that's an eye-opening. I'm not saying that the figure is not right, but, I mean, it's, like, quite striking to me that that many people would not.

But on the survey, Nelson, does that mean that that farm did not ever provide it, or are the date that the survey was done, the facility was not in place? I mean, I'm a little confused.

MR. CARRASQUILLO: Well, we are not -- we are not identifying the farms by name or number.

UNIDENTIFIED MALE: No, no, no, no.

MR. CARRASQUILLO: Even though in terms of the records that we have that is documented. In terms of each Diagnostico represented a specific farm in a specific location. So, that is -- that information can be verified. But it means that it doesn't have that facility.

UNIDENTIFIED MALE: That's what it means. It means that 50 percent -- well, 52 -- 51.3 percent of employers in Florida did not have this portable trailer with the wash facilities with them? On Page 5, it say --

MR. CARRASQUILLO: No, 20 percent in New Jersey, and 48.7 in Florida.

UNIDENTIFIED MALE: Well, 20 percent, that means that 80 percent did not have those kind of --

MR. CARRASQUILLO: Eighty percent in New Jersey has -- provides sink facilities; 48.7 in Florida do not have.

UNIDENTIFIED MALE: Well, you say 48 percent provided a sink in Florida. That means that 52 percent did not provide it. So, half of the employers in Florida don't have this portable toilets and portable washing?


UNIDENTIFIED MALE: I'm surprised to -- the figure. I don't think the figures in Texas will be even --

MS. MULKEY: Well, I, of course, I say this at risk of -- but maybe they're using portable facilities without water. I mean, a lot of the port-o-potties don't have water. Bill.

BILL: One of the concerns when the WPS was initiated was on enforcement. So, the concerns of many of the states who had enforcement in place was the disparity. They felt possibly unfair competition from states who did not have enforcement in place.

I think that's coming up to speed, but I was conferring with Dr. Amador, and I know the states that do have enforcement in place -- and I'll take the one I'm most familiar with, California -- who enacted their worker protection program in 1991, I believe it was, and I might be off a year or so on that date -- where 50 percent of the fruits, nuts, and vegetables, and 17 percent of the cotton of the nation is produced.

The enforcement is done through an established ag commissioner's office contracted through the state. It's extremely aggressive -- port-a-potty -- I'll segue -- port-a-potties have to have handwashing facilities. If there's no toilet paper in there, and there is an inspection, it's a $750 fine. So, it gets your attention pretty quick.

I alluded yesterday, after Janet Andersen's presentation, to the UC system or the land grant colleges. And that's through worker protection and through our grower organizations, such as National Cotton Council that has its own worker protection education system going. But primarily through the extension services -- and I conferred with Dr. Amador on this -- there are aggressive training programs.

In the State of California, we have the train-the-trainer program for worker protection where each farm sends their own representative, and then they come back. On our particular family farm there, we have two people who have gone through that program.

And as an old Army enlisted man, nobody gets away from the training. No matter in the Army if you were a clerk-typist or a musician, you still knew how to shoot and carry a rifle. So, our clerical staff and the bosses have gone through pesticide training, and we do that on an annual basis there.

In California, for an example, the employers who apply for their use permit have to go through continuing education. And which I personally feel that's a tremendous program to keep us updated as to what's happening with EPA and worker protection, reentry, personal protection.

And I might mention also, Nelson, you would be interested in this. Two years ago, we -- they started training us in recognition of heat exposure -- and to the concern that you mentioned there -- because in Texas and San Joaquin Valley it does get quite warm. And you put the PPE on, and it gets a lot warmer.

If I may take just one more second, Marcia, and just brag a little big. We talked a lot about pesticide applications and all. There's a critter that has tried for years -- 30 years -- to invade the San Joaquin Valley cotton crop called the pink bullworm.

The farmers band together, assess themselves, and have a cultural and biological control practice that has kept that varmint out of the valley for 30 years. And through my math, has kept 100 million pounds of pesticides from being applied by dropping 5 million sterile pink bullworm over the valley every day during the growing season and disallowing farmers to have cotton above the ground from the twentieth of December until the twentieth of March.

We also used pheromone-baited traps to catch any blow-ins that might come in. If there happens to be what we call a hot spot, then we use pheromone, which is a synthetic sex attractant -- pheromone-baited pesticide to nail the critter.

So, these are some of the programs I think that the word does not get out of agricultural. But that's probably one of the greatest stories never told.

MS. MULKEY: Okay, thank you. Shelley.

MS. DAVIS: I would just like to make a couple comments. First of all, I thought that Nelson's survey was very illustrative of the kind of problems that workers have reported all around the country.

Basically, his findings of very low levels of compliance is what we have heard and seen in other surveys as well. So, I didn't find those results very surprising. And I think it's very beneficial that he is able to document it as effectively as he did.

We did a study on enforcement -- and I should say Farm Worker Justice Fund looked at enforcement in Florida. Columbia Legal Services looked at enforcement in Washington State. And a consortium of groups, including California Rural Legal Assistance Foundation, looked at enforcement in California.

And so, from the lack of compliance venue, we took the point of view of how good is the enforcement because in our view good enforcement would promote good compliance.

And we were pretty shocked, really, to find that in all the three states that we looked at, enforcement was very poor. And let me give you a couple of quick examples because I don't want to, you know, monopolize the time.

The kinds of things we found is that -- for example in Florida -- when the investigator went out, they didn't take samples -- foliar samples to show that the pesticides were on the crop.

They didn't get medical records of the person who said that he became ill. They didn't necessarily interview the victim even though they always interviewed the employer. So, the kinds of things that we would consider basic enforcement to prove your case of a violation.

Then when we found -- when a violation was found -- and I should say in the Florida study, we looked at 43 complaint incidents. Violations were found in 23 incidents, and only 2 fines were issued. So, that kind of failure to issue a penalty, I think, also was a problem.

The number of complaints are very small, and we think that that's reflective of the high level of fear amongst workers of retaliation.

But the Florida study was really not unique. In California, for example, they just issued their report about two weeks ago. They found that even though the agriculture commissioners found a lot of violations, they issued almost no penalties.

And, in fact, in the urban areas around Los Angeles, there were more fines issued than in the heavy agricultural counties where there is far greater use of pesticides.

So, it was pretty uniform in these three very varied locations around the country that enforcement was very poor.

A final thing I would like to say, the Worker Protection Standard, in our view, is very minimal. There are many important aspects of safety that are not covered, and there are many gaps in the system.

So, if this committee is going to look at the protection of the worker from the point of view of the worker, I think you need to look at what it would really take to put in place a system in which workers would be protected.

And let me just give a couple of examples. One that we think is very important is that the worker should get information about the specific pesticides applied on the farm. There is no training, which we -- you know, known as right-to-know training about the specific pesticides used on the farm. In every other industry under OSHA, they have that kind of protection.

Another big gap that, you know, fortunately, I know the EPA is beginning to work on is the fact that when workers go to a physician and report being ill, physicians do not know -- you know, many physicians -- not all, of course, not all of employers are bad, not all physicians are bad -- but many employers, many physicians don't know how to recognize or diagnose pesticide poisoning -- even something as basic as knowing that if it was an organophosphate explosion, you need to take a cholinesterase test. That knowledge is not widespread.

So, I'm just saying that almost every aspect of this system has holes. And I think, you know, a full evaluation by this committee and recommending what it would really take to make the system work would be very helpful.

MS. MULKEY: Thank you. Sheldon.

MR. WAGNER: Now, Marcia, I want to address two different issues, if I may, so I'm going to warn you.

MS. MULKEY: All right.

MR. WAGNER: One is I want to address Nelson's remarks, and then I want to spend some time about a risk assessment, okay?


MR. WAGNER: First of all, I'm not surprised at Nelson's remarks, either. And the issue to me is the enforcement of the Worker Protection Standard.

And as I view it -- my trips around the country -- is that the enforcement ends up in the hands of, you know, the regional authority who under FIFRA are the Department of Agriculture.

The Department of Agriculture is an organization which is devoted primarily to seeing that a chemical is applied correctly according to label. They are eminently unqualified to go ahead and look at health problems. They don't have the budget, and they don't have the personnel.

And I think that if you're going to ever have Worker Protection Standards enforced, then that particular aspect is going to have to come out of some other department. I think we have to look at the pesticide problem then on a broader aspect because it's an environmental problem, not just a worker problem.

Therefore, for it to be satisfied that we are protecting the workers as well as the environment, we're going to have to go ahead and involve multiple state agencies that are regulatory, such as departments of fish and wildlife, departments of environmental quality, state boards of health, and academic institutions. They have got to come together and then work out a system of protecting the environment and the worker.

But if you go ahead and just allow the Worker Protection Standards to be under the aegis of departments of agriculture, I think you're doomed to failure.

And so that -- I want to make that statement as hard as it may sound. It just won't work with departments of ag.

Then I want to -- so, having said that, then -- if I haven't drawn too much irritation -- I want to go on to the dose assessment, et cetera, of risk assessment.

As a toxicologist, I live by the dose. And the dose that's assessed in pesticides is the DFR -- dislodgeable foliar residue -- times the transfer coefficient, times the hours worked, divided by the kilograms of body weight.

That's for the acute effect, of course. If you're going to do this for the lifetime, then it's a 70-year lifetime assessment, et cetera.

Multiple variables -- really, really strong variables in here, which really make it a, really, kind of a fuzzy thing if you get a magnitude of error, I think that's probably pretty good, and that's not too bad in toxicology to just to be tenfold off. You can live with that a little bit, as a matter of fact.

But as I look at it, I think you're very wise this morning to present -- (inaudible) -- Azinphos-methyl. Why not, it's a Class One tox. It's extremely well studied. You know what to expect in the environment. You can do alkiophosphates on the urine of people, and you got a cholinesterase monitor. Everything is there that you want.

But in most cases, in my judgement, you don't begin to have that kind of material of pesticides. I'm glad to see the industry is starting to do something, also, but they're still studying transfer coefficients.

There is a tremendous amount of material that we simply do not know regarding pesticide assessment and the human being or the environment because we depend upon transfer coefficients.

What that means is, for example -- to me it's very arbitrary. If you work -- if you're picking apples, what it says is that 5,000 square centimeters your body are going to be exposed to foliage, and therefore, DFRs. If you're picking blueberries, then it's going to be 1,000. And if you're picking -- or if you're picking strawberries, it's 1,000 -- blueberries, 2,000.

I think it's pretty darn arbitrary, and that doesn't say that the DFR is going to stay the same all the time because, obviously, it doesn't. The DFR varies from day-to-day.

What's missing, in my judgement, is the human being. The system doesn't allow for us to go -- to assess how much of a compound is left in the body after exposure, excepting on some chemicals. The nature of this organization has been to focus in on organophosphates.

So, now we've got -- so, you've got a system out -- alkiophosphates, which cover about 90 percent of those chemicals and leaves some others. It's great for -- (inaudible) -- can't do it for acephate (phonetic) -- that's impossible.

We've got to have some system for our laboratory analysis that allow you to assess human exposure. And obviously using biomonitoring -- that's fine for organophosphates.

The thing that strikes me about FQPA -- as the way I understand it -- is that we're going to phase the organophosphates out. And if not out, they are certainly going to be decreased. And what's going to happen instead -- as I watch the scene -- is that other chemicals such as the pyrethroids are going to come into use. And they're great chemicals excepting -- and they're based upon something which is natural. So, therefore, they got to be good. But the pyrethroids, in fact, are now Class One tox pyrethroids that are already on the market.

We might as well get ready for the future, folks. We don't have a single pyrethroid out there which is measurable in a human being. And nor do you have a biomonitoring system at all -- of any sort that you can use for pyrethroids.

And I would suggest that one of the things the EPA should be doing is looking toward the future right now about how you're going to assess all these new chemicals that are coming on the market. The majority of them, which are pyrethroids, in fact, and they're great. But let's look at the problems that -- let's look at the problem of how are you going to assess human exposure? How will you calculate a dose for a pyrethroid?

And I think you should be looking at that now, and I want to make that point this morning because I think for the future it's going to be very important, along with my concerns about organophosphates.

MS. MULKEY: Okay, thank you. Jacqueline.

MS. HAMILTON: Thanks. I just -- I appreciate those comments very much. I do think it's important that where we do have the capacity to do biomonitoring, however, especially for something as a class of chemicals as widely used as the organophosphates that we should be. And I share with Dr. Wagner the concern that the presentations that I heard this morning really seemed to be a lot about things that didn't involve people.

We know how to measure cholinesterase inhibition. All kinds of scientific bodies have said, yes, okay, this is the mechanism of action we're going to agree is the common mechanism for organophosphates.

And yet, we're -- I don't hear anything about efforts to try and -- in a setting where you know what has been applied per acre, to then go in, you know, intervals after that to monitor what's happening with the workers. So, I find that concerning and disturbing.

I'm also concerned about this issue of, sort of, assuming that everyone is in compliance, either with the maximum label rate -- which is what's legal -- or with cultural practice, which increasingly is making its way into the Monte Carlo analyses as the consideration for exposures.

When you don't have people in compliance with either of those two scenarios, what happens? And do we have any idea how much people are, or aren't, in compliance with those two scenarios? And I think the answer is no, and I would appreciate it if someone could address that.

And then finally, I -- well, almost finally -- I think it was Tim, maybe -- I don't remember -- who was saying that there is some plan coming up to deal with this issue of kids in the field, women in the field, pregnant women in the field, and trying to do something around that.

It sort of was mentioned very quickly, and I would really like to hear more about any plans around that, given that there is -- depending on the size of the farm, and who owns it, and so forth -- in some cases, there are virtually no restrictions on who can work in the field. And we know that children as young as 10 are legal to work in fairly large farms. I think that this issue is just absolutely critical.

MS. MULKEY: Any of you want to take on trying to -- and then I'm not --

UNIDENTIFIED MALE: I can get it started. I think it was Paula that mentioned that the ARTF was looking at some of the women in the field for exposure studies.

MS. HAMILTON: But wasn't -- didn't someone this morning say something about -- yes, I thought so.

UNIDENTIFIED MALE: But I do have something to say on that. We have based it -- and I think it was the AZM technical briefing -- and maybe it was Shelley that had asked the question -- but what about 12-year-olds that are also harvesters?

And we have been looking at that. We're going to -- one thing we have looked at is that a 12-year-old -- when you look at the ratio of surface area to body weight -- is probably -- has a -- I think it's about 20 percent, correct, Jonathan? But a 20 percent bigger -- a 20 to 30 percent bigger, you know, more chance of getting exposed, basically, in plain language.

But on the other hand, we also believe that when you're looking at the productivity of picking something and the actual how much exposure and contact you're going to get, we need -- we don't have data for that, but, you know, it's most likely their productivity and their exposure levels -- they are going to probably drop and maybe even account for more than that 20 percent.

That is something, you know, we're not finished looking at, though. You know, that's not going to be the final word.

The other issue you had brought up was about worker safety and training and tie that to risk assessments. We look at our risk assessments, and you certainly -- you can see there is -- and especially for handlers -- you have a high variability of exposure. Exposure is highly variable.

Are you mixing and loading a wettable powder? Are you standing upwind, are you standing downwind while you're doing it?

And one thing that we definitely need to link and look more towards the future is these training programs. Training programs are definitely necessary in order to do an accurate exposure assessment. You want to try to get these outliers out of the system, and the best way to do that is worker safety training, especially for things like fumigants. I mean, that's something we certainly rely on. And if anybody else wanted to --

MS. MULKEY: Well, this issue of women and children in and around application scenarios is really twofold. One is people who are actually working. And there is the young, but legal, worker issue. You know, children of farmers, and that's the issue you raise, and Tim spoke to that a little bit -- our attempt to be sure that we're including them in our analysis scenario.

I think especially for things like developmental toxins we pay some special attention to -- I mean, I don't understand the details of how we do it, but is it right to say we have some?

UNIDENTIFIED MALE: A good example -- let me back up here, too -- is when we calculate REIs and to bring us into Worker Protection Standards is the crops or crop advisors when you go out there scouting in the field, they -- a lot of issues have been coming up now with us setting REIs based on the active ingredient through FIFRA when the WPS allows crop advisors to go in prior to the REI based on the handler PPE. Whatever the handler needed to wear, they need to wear, also.

And I believe there's a clause in there where it says, or what the crop advisor believes is necessary. And for a developmental concern, if you have a pesticide, the only thing that you're looking at is a developmental concern. Perhaps the tox categories -- there's tox category three or four will show a caution label, yet it doesn't say that it's a developmental effect.

So, when a crop advisor looks at that, he says, well, I've used plenty of these pesticides before. This is a caution label. We're three days after the application. I believe he can go out there without putting on those coveralls like the handler had to wear.

But that lacking piece of information would be, well, this is a developmental effect. So, we are pushing, and we are bringing that into our risk assessments. And if you have seen some of these drafts that are going out and the REDs, that we are requiring entry restrictions for something like a developmental effect, that's going to be a crop advisor.

MS. MULKEY: Those are examples of ways that we're trying to take into account for the workers. In addition --

MS. HAMILTON: I'm sorry, can I -- I didn't entirely understand what you said. So, you're saying that assuming that the crop advisor is a woman, then you're saying you would have an increased reentry --

UNIDENTIFIED MALE: No, we don't make the distinction if it's a woman or not. I mean, the label says, if you're a crop advisor, you have to wear this PPE until Day 5.

And no matter what, even if the caution label -- you cannot go back and say, take those coveralls off. You have to stay with those coveralls on for whatever the risk assessment had said based on that developmental tox endpoint.

MS. MULKEY: The other half of it I wanted to mention is that children or anybody who is exposed -- not because they are workers -- but incidental to the application -- either at the border of the field, or children of farm workers who may be present, you know, in and around fields. And we have begun to look at that, too.

We actually plan a presentation to the Science Advisory Panel, which begins to approach those issues in September.

MS. HAMILTON: And, of course, we've petitioned you to do that, too.

MS. MULKEY: Well, petitions are part of the way that we get -- our attention is gotten. There's no doubt about that.

MS. HAMILTON: And finally, I just want to make a comment that, also, again echoing what Dr. Wagner said -- I don't remember a number, although I know I've read this in the last year or so -- that it's actually only a tiny fraction of the active ingredients for which we have any capability of detecting them in the human body. And I think that's something that really merits some focus.


MR. BENEDICT: I debated whether I was going to comment or not, but I -- after the departments of ag got painted with such a broad brush, I thought maybe I should. I would point out first of all that in New Jersey the program is run by DEP, not by a department of ag.

I don't think that good or bad programs focus on what programs are situated. I think they focus on the employees of the program. So, I don't care if you're in a human services agency, an environmental agency, or an ag agency. The success of a program probably depends on the employees in the program.

I would go on further to say that at least in the Northeast, I think programs are better coordinated than you might give credit for. I give the Agency a lot of credit for forcing this issue. It really started with a groundwater strategy.

A groundwater strategy required agencies to have coordinating committees to make sure that environmental agencies, health agencies, and ag agencies were talking together as we talked about pesticides.

We hired somebody with a health specialty in the mid '90s because -- but we're not doctors, by the way. I'm in a department of ag. We'll never be doctors. That's not our background. It doesn't mean, though, that we can't talk with toxicologists and health departments. There are two there, we talk to them on a regular basis. We talk about these kinds of issues.

You know, this program started -- the focus of this program when it started was compliance. It came out in the National Guidance the first couple of years. It was a compliance-based strategy.

Part to this time frame we're talking about covers that compliance time. Part of this time frame we're talking about now covers the enforcement aspects.

I'll tell you there are lots of inspections done. Sometimes -- I always tell my inspectors, collect the sample. You can't go back and get it. We may not analyze it, but if you don't collect it, we can't analyze it. That doesn't always happen.

There -- so, you know, I think that there is no program that does everything right. If there is, I would like them to speak -- stand up and so I can go chat with them about this a little bit.

I'm a small town country boy. We try to do things right. We don't always do things right, but we try to learn from our mistakes. I tell all my staff, you have a right to make a mistake. I'm only going to get upset if it's the same mistake over, and over, and over again. So, let's improve.

So, hopefully, we can go on. I don't think it's just the Agency that has an interest in this. I had a communication from GAO, and they're also going to look at this issue, so, I'm sure we're going to kick this around a lot more.

But I guess I do get bothered a little bit when we paint everybody with a broad brush. I think we should -- I think there is reason to paint with a broad brush to raise the issues. I don't think everybody, though, automatically ought to assume that color. Thanks.

MS. MULKEY: Okay. Well, we will call on you, Beth, but since we started at -- we'll call Paula. And, Shelley, is your card still up?

MS. DAVIS: I'm up again, if you don't mind.

MS. MULKEY: Okay, that's fine. We'll come back to you. I just wanted to be sure.

MS. PAUL: All right. I would just like to briefly comment on two issues. One is the biomonitoring, and probably to point out that for a number of the studies we purchased -- although we were mainly interested in the transfer coefficients -- those cities did include biological monitoring.

Also, that having been involved in the conduct of some of these studies within our company, I can also say that for many chemicals developing, it isn't a matter of registrants not being willing to develop biomonitoring procedures. It's just that depending on the nature of the chemistry, it can be very, very difficult.

And it's always our preferred means of monitoring when we can, but it's just so often the chemistry doesn't lend itself. And maybe in the future as, you know, science marches on, we'll find better methods. But what we have --



-- both in penetration -- I mean, that's another side issue that some of the ARTF data has been able to give us better information on clothing penetration.

So, that I've noticed -- and I think Tim can probably speak, and Jonathan can probably speak best to this -- but that over time, our estimates have been creeping more and more to greater accuracy. So, I'll just point out that.

I also appreciated Nelson's presentation, and I think he pointed out some interesting areas. And I was wondering if -- I don't know very much about the training aspects, but I was wondering, you know, there has been a lot of work done in the health care industry in terms of communications with different ethnic populations and differences in the way you train and communicate health information.

And I'm just wondering if there is an opportunity for a partnership there in terms of making sure that the way we're training people is the way -- is the best way so that they're receiving the information and understanding it.

MS. MULKEY: Well, as part of this reassessment, that would seem to be an excellent opportunity to -- Kevin, I take it you would be receptive to tapping into that reservoir of expertise.


MS. MULKEY: And because the subject of biomonitoring has come up several --

MS. PAUL: Oh, wait, one more. And, Marcia, I do want to remind you, too, that you were going to address the human issue.

MS. MULKEY: Oh, okay. I'll do that after we provide this little snippet of information.

MS. PAUL: Okay.

MS. MULKEY: And we'll still come back to Beth and Shelley. It occurred to us that you might be interested in knowing about a national biological testing effort that we don't have the -- our in-house expert on this, but Beth Doyle who is one of the branch chiefs in our Health Effects Division is going to at least give you a little bit of a sense of the study that is conducted nationally.

MS. DOYLE: Well, I believe a number of you probably are familiar with the N. Haynes program. There have been a number of repetitions of this particular survey over the years.

It's a health-based survey. Part of that survey in the last round in Haynes 3, which was done almost 10 years ago now, did collect some biomonitoring data on OPs -- or actually not OPs, but it was a particular metabolite of -- that occurs with two pesticides.

And we have looked at that data to some extent to see what we could learn from it about the exposure to these products nationally. It's non-specific, we don't know about the source in this case, but it does give us a sense of the overall exposure.

And the step that we've taken in the next round is we've worked cooperatively with Health and Human Services in designing the next round of the Haynes survey that will go out this next year into the fields. I believe it's this next year -- has it started? I don't think so. It hasn't started yet. Thank you.

The collection of urinary samples for that particular process will have six pesticides tracked and will allow us to do a little better look at trying to pull apart what the exposures are that we're actually finding. So, we have a sense again of trying to see where we are with regard to our estimates overall.

Another aspect, though, we have a number of other studies that we are monitoring. We are following literature sources. More and more researchers now are beginning to publish on this area of biomonitoring small studies, but certainly in peer review journals. And again, Ag Health is collecting samples.

We are fortunate enough now to have more epidemiologists on staff. We're able to work with this sort of data and help to relate it to the exposure assessments. So, we are entering into a phase now directly relating our exposure assessments -- or more directly relating our exposure assessments to what we're seeing after -- with experience in the field.

MS. MULKEY: I will now keep my promise to clarify the Agency's posture on human studies. Last July, the Agency announced that it was concerned -- it had never required nor stated a desire to have conducted studies of the toxicity of pesticide in humans.

This is sort of what I call the NOAEL studies, but the study is designed to determine what is the toxicity level.

And that the Agency had concerns about these studies, and the Agency official stated that we would not base any final regulatory action on any of these types of human studies unless and until we had a comprehensive policy in place to evaluate the ethics of any study that we might consider.

Then the Agency convened a very, sort of, multi-star group of ethics experts through the combination of our Science Advisory Board and Scientific Advisory Panel, which held a public meeting in December. It was a very lively discussion of these issues over about a two-day period.

Those two panels then have been preparing a combined report. They have not yet produced for us a final combined report. And they have decided that the issues are so complex, and their dialogue would benefit from another day of meeting. I believe that has now been calendared. Or in any event, there is an effort underway to do that soon.

So, that's sort of the state of play of the issue of the consideration of human studies from the point of view of the ethical concerns.

We have had in our -- in our files from previous submissions some conduct -- conducted by pesticide companies, some just available in the public literature, or otherwise conducted of these types.

We've presented at that meeting in December a sort of an inventory of the studies of that sort that we have in our files. And we have in the past taken these into consideration for some chemicals in reaching conclusions -- either about, you know, about the toxicity -- and therefore, in turn, about the risk.

And so, we are working to sort through, sort of, the science of those studies that are in our files. We have also received some additional ones, and we expected that. That's part of what gave rise to this announcement in July. It had come to everybody's attention that some of the OP registrants, in particular, were conducting these studies and planning to submit them.

And so, we continue to work through the issues relating to the specific studies and the science questions related to them internally. But we are still abiding by this public statement of our position regarding our expectations regarding human studies and their use, and our intention to have in place a policy relating to ethical acceptability. So, that's the answer to that question.

Okay. We can go ahead. Now, I think, Beth, was next.

MS. MARSHALL: Oh, one question which occurred to me as -- listening to discussion. Going back to another aspect of FUPA -- the extra safety factor for children and their exposure.

It seems to me that the families of farm workers who do not work in the fields would probably have a considerably higher exposure because they would handle the clothing of farm workers. And I would imagine that the washing facilities are somewhat limited in many camps for both clothing and humans. I'm sorry?


MS. DOYLE: Well, even aside from handwashing. So, I would think in the 10X -- is there some way that the 10X calculations are going to take into account clusters of children like these who, undoubtedly, have a higher exposure than the general population of children?

MS. MULKEY: Well, the consideration about whether to retain the 10X factor is both a toxicity-based consideration and an exposure-based consideration.

And this issue of looking at -- what I will call incidental exposure -- that's what I was describing when I answered.


MS. MULKEY: Jackie -- that we're trying to look at those kinds of -- I'm sorry. Thank you for -- because, obviously, I've created a habit here I've now got to work on breaking.

And I don't mean by that to say we are ready tomorrow to analyze the impact of clothing coming home and washing it. But we are working through these kinds of issues. Anybody want to add anything to that?

UNIDENTIFIED MALE: Marcia, isn't the 10X factor a dietary factor?

MS. MULKEY: It's a FQPA factor, but remember that if -- so, you would only --

UNIDENTIFIED FEMALE: Residential exposure.


UNIDENTIFIED FEMALE: It talks about residential exposure.

MS. MULKEY: Because of aggregate, you may take into account exposures to children and infants, as in the drinking water, in the residential -- in the incidental situation.

So, while it wouldn't be considered in a worker exposure situation, because it relates to the FQPA, and the FQPA requires an aggregate exposure, it could come into play with regard to some of these other exposures. Yeah, Kevin.

MR. KEANEY: In the fall, we're beginning two studies -- one in Pennsylvania and one in New Jersey -- that might get us information on these particular issues. UNIDENTIFIED MALE: In the fire, Kevin.

MS. MULKEY: I don't think that's going to happen.

MR. KEANEY: In the fall, we're beginning two studies, and one in Pennsylvania and one in New Jersey that's going to be dealing with the home situation and might provide us some degree information on that. I would ask Anna Marie Osorio from my staff to give a bit of an outline on what the nature of these studies would be right now.

MS. MULKEY: Yeah, just a brief.

UNIDENTIFIED FEMALE: Yeah. This is really brief, and I want to acknowledge that Nelson got -- (inaudible) -- from CATA also involved in a collaborative effort with Rutgers University. And they're looking at two sites -- looking at farm worker families as a whole and seeing multiple routes of exposure to primarily OPs. And soon the commodities have already been selected and all that, but I think if everybody is interested, I'll be hanging around during the break. I would be happy to talk to people about it. I know your time is limited.

MS. MULKEY: Okay. Very good. Thank you, Kevin. I believe Shelley was next.

MS. DAVIS: When the discussion began today about how EPA figures out exposure to handlers in reentry intervals, what struck me is that the underlying assumption is that everyone follows the rules exactly correctly.

And as an example of something that seems kind of odd to me was that one of the speakers mentioned that a handler applying Azinphos-methyl in an open cab would get less than a teaspoon of diluted spray.

And what surprised me was that I've talked to a whole number of pesticide applicators in Washington State in apples who say they're getting sick all the time. So, there's kind of a disconnect there.

And what that really brings to my mind is in terms of the policy things here is that it seems to me that there's got to be a consideration of not just if everything worked perfectly, but the variability in conditions.

The fact -- you know, as Nelson's study points out and others have -- that there is noncompliance out there, or that there is wind conditions, which would affect how much of an exposure people actually did have. One thing in the law's side is that in a products liability context, the law requires a manufacturer to think about foreseeable misuse, and this could be unintentional or intentional. And that kind of factor doesn't seem to be a part of this consideration.

Another point that I think that Dr. Wagner pointed out, which is I think another really key thing in figuring out whether your assumptions really are good enough, and your conservative assumptions are really good enough is the extent to which you can really verify in life whether what you're thinking is actually happening.

And I would think, you know, for example, as you go towards typical rates of application as opposed to maximum label rates, you have to be asking yourself, how sure are we that this is really right?

And the fact that, you know, that Marcia mentioned earlier on which I think is completely right that any agency's ability to have a very good handle on what happens on the farm given that there is -- I don't know -- 50,000 farms.

There's some -- you know, many, many farmers, many more than any agency will realistically ever visit. You know, you're not going to be able to really know what goes on in a lot of places.

So, what I'm just saying is that to me, you've got to modify your best case scenario by the fact that there is widespread noncompliance, and your ability to ensure compliance is pretty low.

UNIDENTIFIED MALE: I have a few things I can probably respond to. For the Azinphos-methyl -- the airblast with the teaspoon level being exposed to on an open-cab tractor -- that amount is actually what is being deposited on the skin, underneath clothing, and these were actually monitored values. And what our assessment shows there -- that the MOEs are of concern, and we would be predicting that there would be some type of an effect.

So, based on that assessment and hearing, you know, the -- all those anecdotal -- there are some incidents, you know, that shows what our assessment said.

The variability in conditions and the winds -- that is certainly true. Exposure for handlers is highly variable. And the data that we have, which is roughly 2,000 replicates of individuals going out and doing some type of a pesticide task -- either being mixing-loading or applying the substance -- they are done with real farmers, real workers.

Those conditions over different -- 100 different studies, different sites -- we are capturing some of that information. And for people that want to look at PHED itself, we do capture the wind direction, also. You know, a lot of wind will switch, you know, in your face, out of your face.

So, we haven't -- we don't have enough data to show the trend -- I mean, to show exactly what it's going to be, but I think you could look to see that the trends, you know, if the wind is blowing at you, perhaps your exposures will be a little higher.

But that variability is captured, and one of our things we have is an evaluation document on how to evaluate these handler studies from PHED.

And one of the things we try to push is to get more than one study even if, say, Paula submits a chemical-specific study that she has done for an airblast applicator. I have six, seven other studies that are generic.

I would take her data, mix it with my six or seven other different -- perhaps -- say if it's a groundboom -- maybe each groundboom had a different length. The tractor was a little bit of a different configuration. We would mix all those six studies together to come up with an estimate.

And then for verifying the exposures or what actually happens in real life, one thing you can look at is California. They do do cholinesterase monitoring, and they have a Title III -- I guess is what it is -- is if you have a certain depression of cholinesterase inhibition levels, that they actually pull the worker out of the field.

And this goes back to like I said earlier, a lot of this exposure needs to be followed up with worker training, such that if the same worker you can see over the month or two, or over the season, the same person is being pulled out each time, that's a training issue. They're not -- their personal hygiene, perhaps, is not quite what it should be. They're not being careful or whatever have you. That type of a program will help our exposure estimates.

And then lastly, the typical versus maximum. This will be more for a risk assessor to paint the full picture. We want to -- we have a lot in the past just used that maximum rate because we are interested in national -- right now a national label.

And we do get criticisms -- say, one person in one region or state say, we never use that maximum label rate. But perhaps another state, they use that maximum rate, you know, every time they use it.

But if we can get more information to characterize what is happening, the risk managers will know based only on this infestation, that's the only time we have to go to this higher rate. The rest of the information shows we have these risks. And perhaps they can use that in some type of a program on how to use the chemical. I'm not sure if I've answered all your questions, but --


UNIDENTIFIED FEMALE: Just a -- because I think that -- a worker risk assessment is different than a dietary assessment, where for dietary assessments you might use, kind of, you know, an estimated, you know, table, market basket, or tableside. But for worker assessments, you always aim for the maximum rate, the maximum number of applications that are on the label.

It's a different process. It's a more stringent process in the sense that, you know that might happen, but, you know, as Tim said, if you have more information to know that that doesn't happen, then you either amend your label, make it more specific, or whatever.

But it's a different -- it's not the same as dietary where you may use anticipated residues. You're always aiming for the highest -- do your risk assessment at the worst case.

UNIDENTIFIED MALE: And an example where that could actually come into play is perhaps the typical rate, you didn't need to have those coveralls on. And in a hot climate that's good, but if you got the infestation where you got your rates and order a magnitude higher, perhaps that's where you have to wear the coveralls even though it's a little hot. And we try to get around that heat stress problem there.

MS. MULKEY: Okay. Jay.

MR. VROOM: I think Kevin and Jay referred earlier to meetings at the end of July and the end of September around worker risk assessment. What kind of registrant and other stakeholder involvement will occur, and will all those meetings be public?

UNIDENTIFIED MALE: The meeting in late July is really a focus group with probably no more than a dozen or so people outside of EPA. It will be USDA and a land grant university.

Beth is planning for the larger, late September meeting, which will be a much broader meeting. And it's an already scheduled meeting, and -- (inaudible) -- of the plans for -- (inaudible) -- beyond -- just taken by PHE folks.

UNIDENTIFIED FEMALE: Those meetings are always broadly attended as primarily PAT, (Pesticide Applicator Training). And it's also a meeting in conjunction with our PIA program -- the Pesticide Impact Assessment Program.

But those meetings are usually attended by state regulators, oftentimes. John Empson -- you host those types of meeting, you know, have state people there, company people, others.

UNIDENTIFIED MALE: You're talking about the regional meetings.


UNIDENTIFIED MALE: The regional PAT meeting occurs -- (inaudible). There are four regions throughout our land grant system. The one in reference that Theresa is referring to is the southern region, and that's basically the 12 or 13 southern states.

The attendance there are the state pesticide coordinators from those -- typically, the 12 or 13 southern states in this case. Also, the state lead agency and/or the pesticide regulatory agency from those same states.

And depends on the topic -- the -- obviously, the EPA regional people as well as headquarters people -- depends on the topic and the severity of the matter at hand. But basically that's it.

MS. MULKEY: But they are open to the public?

UNIDENTIFIED MALE: Oh, certainly, yes.

MS. MULKEY: Jay, actually, part of the planning in July is to look to see if this can be planned in a way that it's the kind of thing we might invite the TRAC members to, to sort of adhere to that promise that we would have some sort of appropriate open forum.

I don't know if you were here when I opened the remarks on this by saying this meeting is not intended to fulfill that promise exclusively. But we are looking at whether the September meeting might be an appropriate forum.

And I think we were planning to consult with the TRAC members to see if there was receptivity to that. I don't know if that process has started or not.

UNIDENTIFIED FEMALE: (Inaudible) -- asked John Ehrmann to --

MS. MULKEY: We asked John Ehrmann to explore that.

UNIDENTIFIED MALE: Okay. And I think I agree with the idea that we can't bring all of this to closure here today. And there's a certain sense that I have that the initial, sort of, phase of discovery and understanding that this is a very complex area is just hitting many of us -- all of us.

And we probably won't get there by the end of September, either, in terms of a broader public understanding of, you know, are we in pretty good shape and getting better, or are -- is the Worker Protection Standard a disaster and needs to be completely restarted? But there's just so much complex information that has to be understood. And the Agency is obviously doing as well as you can with the tools that are there, but then trying to communicate what is happening just in terms of the standard and its application and compliance, much less enforcement, that's an enormous undertaking. MS. MULKEY: Well, we are aiming at both transparency and continuous improvement, as Phil said. And every effort at improvement then creates a new transparency challenge.

Well, this is coming to conclusion pretty much on time. We have a window for public comment, and then we are scheduled for staying together until 1:00.

I have only a few materials to supply to you, but I had hoped that we could offer you as much time as you're interested in in this last hour in talking about the way you would like to see this operate.

It looks like Jacqueline wants to make a comment, and that's fine.

MS. HAMILTON: Yeah, I -- just one last thing before we move off of the worker stuff. I was really struck by -- I realize EPA will at some point take some regulatory action on Azinphos-methyl at some point.

But I said this at the technical briefing, and we've said it in-between that the slides that were put up here are demonstrating that currently there is astronomical and completely unacceptable worker risk. Even with maximum personal protective equipment, you still don't get above the margin of exposure.

But if you required all mixing and loading systems to be closed, you would deal with a huge amount of the handler -- pesticide handler risk. Things like that where you've -- yourselves identified some pretty significant ways of addressing what are universally acknowledged, I hope, to be completely unacceptable risks.

I would hope that as these things continue to come up, that instead of just waiting for a period of time to, sort of, see what comes in that when such a finding is made, there might be some proposal for regulatory action when there is such an obvious solution as that one.

MS. MULKEY: We're trying to be particularly mindful of the use seasons as it relates to these issues we're identifying.

MS. HAMILTON: Well, even, you know, whenever you're going to say it takes effect, proposing to do it, I think, would be significant and would say that the Agency regards it as a priority, which I think is part of the problem.

MS. MULKEY: Thank you. Jose, you had additional comments?

MR. AMADOR: When do we meet next?

MS. MULKEY: Well, that will segue into the kind of things I need to announce to you. But --

MR. AMADOR: You know, because the reason I asked that question -- there is a tremendous disconnect here from what I've gathered between what some of the group representing farm workers, some of the groups representing the state, and some of the groups representing the university, and even some of the growers' group.

And I wonder -- and I don't know what I'm getting myself into -- but if I could talk to Nelson, if I could get some of the people -- let's take an area like the Lower Rio Grande Valley. That's heavily agricultural and farm worker intensive.

And if we could talk to some of the groups there and talk to some of the farmers' group -- maybe get Kevin to help us out, and the Texas Department of Agriculture. And maybe if we could sit together and find out what the situation is and report back to this group -- I don't know, maybe by next time, or maybe the time after next -- would that be something that would be helpful to this group?

MS. MULKEY: Well, hold that thought because it does relate to the whole question of how we work as a group. We have the public comment scheduled for 10 after -- and there are only two, and it won't take very much time.

Let me say a couple of things to get you thinking, then we'll have public comment. Jim may have some questions he wants to get us thinking, and then we'll hear from you for the remainder of the day, sort of, how you want to proceed.

Here is a couple of things to get you thinking. One is that the charter of this particular advisory committee does, in fact, expire. So, this committee as currently constituted will cease to exist.

We have every expectation of seeking a renewal of the charter, and then we have the opportunity of developing the membership of the newly chartered organization. And we understand the value of continuity. We know that you and we have invested in this group, but we also need to look at the question of whether we need to have some rotation of membership.

Your feedback the last time we raised the questions of the size of the group was almost uniformly that it shouldn't grow significantly in size. And that, by the way, conforms with our own perceptions and expectations.

So, there is -- it is likely there would be some alteration in the mix of membership. You don't grow, but you want -- and you want that over time in any event, and that's an appropriate time.

So, there is the rechartering that we need to go through. There is the solicitation of interest in membership, which will be done formally through a federal register of solicitation, plus we will continue our effort to communicate with you and others of our stakeholders directly so that you don't have to just watch the federal register.

I'm sure we'll give notice to the TRAC members. I'm sure we'll give notice to other, sort of, lists of addresses of our stakeholders that that federal register solicitation is occurring.

We, of course, will strive for a balanced and new advisory committee. And we, as I said, we will be mindful of the value that comes from some kind of continuity.

But if you have input about that, and your thoughts about that, that would be good to address in this next period.

We had some discussion yesterday about the role of work groups and the interaction between work groups and this organization. As the results of some off-line conversations, it seemed appropriate to float a few ideas about how you would interact with work groups, which we'll try to do when -- as part of the hour.

But, basically, the idea will be to have a range of approaches, which includes, basically, you're just encouraging the Agency to take the views of the work group, and you're not getting involved in it. That's sort of one extreme. Take the views and do with them what we will kind of thing without your endorsing them. At the other extreme would be where you would, basically, have the work group brief you, and you would get fully engaged, and then you would, sort of, convert their advice into yours in some formal or semi-formal way.

So, that's that set of issues. Then there's agenda planning and agenda follow-up. Have we got it about right? Do we need to go to another level in terms of the way we approach both the agenda, and how we capture what we accomplished?

And then Jose has now added as part of agenda follow-up, when a topic like this creates some energy, as Inerts did, you know, what are our choices in terms of building on that energy from within this group? Inerts we went to formal, long -- relatively long-term sustained work group approach. Are there less formal -- that's what I understand your question to be with a particular reference to this topic we've dealt with this morning.

So, those are some framing questions. If others of you have framing questions, as soon as we do public comment, I recommend that you offer them at the beginning so that you'll trigger thoughts from others. Jim, do you want to add anything at this stage?

JIM: No, I'll talk when we get back to it.

MS. MULKEY: All right, all right. So, we'll now do the public comment, and we have three commenters. I went from two to three.

So, we will start with Elizabeth Knee, and perhaps she will explain her affiliation or reason for appearing since I don't have an affiliation. Is Elizabeth here? All right, we'll call on her again.

It's exactly the time that we said on the schedule we would have public comment. Mark Jensen of Jensen Ag Consultants.

MR. JENSEN: Thank you. I've enjoyed the discussions over the last couple of days. I'm involved in contract field research for industry and have worked a lot with import tolerance studies down in Central and South America for about 10 years.

I also farm in Louisiana. My relatives farm in northeast Nebraska and also in Germany, so that's kind of my roots here.

But I've been involved a lot in studies, again, on OECD submissions and import tolerance submissions to the EPA on bananas, citrus, coffee -- thank goodness for coffee -- sugarcane -- those sorts of things.

And I have some comments. Some incorporate some of the issues from yesterday, and some from today. Regarding yesterday, the 860 guidelines that concern the current number and country field trial locations -- the requirements for import tolerance studies. There was some discussion in that regard.

The number and the way the system is set up now is sufficient. I did want to point out from the sponsors' and registrants' view that they don't always uniformly execute the GLP studies the same -- especially considering all the logistical and compliance issues that are involved.

I was glad to hear that data quality was mentioned yesterday. I think that's a very big concern nowadays. Sponsor managements are under considerable budgetary constraints nowadays, and their commitment to their respective QA programs sometimes suffers in this regard.

There was also discussion yesterday -- worker exposure and effete issues are separate from -- and should continue to be separate from -- the issue of generating residue data for import rack and processing studies. The two issues just aren't related.

In these types of studies, extra worker safety procedures are in place, and that's to avoid contamination -- especially of the samples that are destined for analysis.

In addition, no company wants any sort of PR disaster, and this has happened in the past. I've worked with companies trying to help them get their PPE equipment down to the workers in Central and South America to avoid any sort of PR mishap or poisoning of the workers or the foreign population in general.

The cost to industry for these kinds of studies are extremely expensive. What industry tries to do now is combine one study to suffice the OECD submission as well as the U.S. import tolerance submission since a study may be over six or seven countries, and it just involves a lot of time as far as registration is concerned and dollars.

On one handout yesterday it says, currently, EPA assumes that residues in imported commodities will be the same as in domestically produced commodities. This assumption may under or overestimate risk. If a commodity has grown, like sugarcane is grown here as well as in South America, they're completely different. They really are.

The cultural practices are different. For example, sugarcane -- there's a three-year harvest period here. It's five years down in South America. Bananas are grown differently. The pests are different. There is a disease right now in Central and South America called sigitoco (phonetic) on bananas. It is running rampant. That disease isn't near the problem here as it is down there. So, the two are quite different.

MS. MULKEY: Are you pretty close to

completing --


MS. MULKEY: Because we certainly can make an opportunity for you to provide additional information in writing or engage with us in some other way to --

MR. JENSEN: Yeah. I was going to submit these. My last comment had to do with the occupational assessment situation with Azinphos. There was -- I just got the literature back that I obtained from the last TRAC meeting, and I think it's something that Jacqueline had just mentioned a minute ago.

And that has to do with handlers. One of the slides that was presented during that meeting says, out of 14 handler scenarios -- now this is for Azinphos -- only 1 has an MOE above 100 when considering short and intermediate exposure.

Someone asked the question at the TRAC meeting, what did that involve? And someone mentioned it was the flaggers in cotton fields. Well, that issue is irrelevant now because all the aerial applicators use GPS equipment. So, I think we have to look at the new technologies that industry is presenting.

And my last comment has to do with industry right now is working very diligently on the whole electronic submission issue. And, hopefully, that will help EPA in the submission progress.

MS. MULKEY: Thank you. And finally, Adam Goldberg of the Consumers Union.

MR. GOLDBERG: I just wanted to comment. I appreciate your comments on the membership of the PPDC in the future, and I've been speaking to Margie about it. And Consumers Union is very much interested in continuing to work -- regaining a seat on the PPDC. I think it was always our intent to remain a member of this group, and so, I just wanted to express that interest.

And I know I'll work with Margie and with the rest of you as you have this discussion afterwards and whatever comes out of it to regain that seat, so, thank you.

MS. MULKEY: Okay, and thank you. Okay, Jim, did you want to fill this -- there's a little human interest story here.

MR. AIDALA: Well, yeah, I had one other less human interest story I'll talk about after that. First, the human interest.

The gentleman -- you may or may not have noticed in this morning's Washington Post they have a picture on the front page and another one inside of people getting the new laser eye surgery technique.

And it just so happens that the photo of the gentleman getting treatment in the inside part of the story, Page A17, is the guy that's the head of the company that runs our audiovisual system. So, which may explain why --

UNIDENTIFIED FEMALE: Except they were not at the infamous meeting at the Shoreham where you had no -- that was not them. But all of the successful meetings are AVF, and Jeff, the son, is actually here. He's not in the room, but we want to wish the father well.

MR. AIDALA: Right. All those people who make these things possible -- and not just -- well, we're always trying to give accolades to Margie, but also even behind those scenes, far behind the scenes, are the people who actually make the microphones work, and the trains run at least on track, let alone on schedule. And so, we just want to point that out for some reason.

UNIDENTIFIED FEMALE: It was on the front page of the Post.

MR. AIDALA: I just had a comment about whether or not since the gentleman has got eye surgery, whether that's not why he's a sound guy, but that's a whole other question.

UNIDENTIFIED FEMALE: It was also shown, and the people were walking through a mall, probably eating ice creams, and they see an eyeball being operated on right in the window of a store.

MR. AIDALA: Whatever. Well, whatever new -- other marketing and retailing concepts aside, no, so that was one part that's a human interest story.

The one thing about membership and other issues I wanted to raise, too, is, obviously, in this forum and other forums outside of, sort of, advisory committee meetings and all, the question has been raised about the TRAC process, or son-of-TRAC, will there be a TRAC, you should have a TRAC, don't do TRAC, I don't like TRAC, I resigned from TRAC.

All kinds of things where, obviously, I think that's some of the considerations as we think about how to get advice about the program and FQPA.

And that would be something I think that as we go now into some discussion about membership we want to hear about. And on the one hand, this has been a -- more of a -- the working man or working woman's, you know, sort of -- (inaudible) -- pesticide issues.

We bring things to you that are a little less of the highly visible issues, things to get input from you as members of the public and various stakeholder organizations and constituency groups to help us do our job and, sort of, a lot of the day-to-day work, if you will, that goes on in pesticides as opposed to the stuff that either gets subject to everything from congressional hearings to press conferences, and all the other kinds of ingredients that go into our modern policy-making apparatus.

And so, again, I would just ask that that's something to be talked about. In our discussion of the TRAC, the TRAC will have one more meeting, and it will be the last meeting of the TRAC. But that's certainly not to say we don't want to have input from representative groups on how we implement FIFRA, Food and Drug, FQPA, and just run our programs in general.

And I guess that's just something that we should put, kind of, at least in this mix of this discussion, and everything about membership, size of the group, and also leadership because one of the other issues that has been raised is having senior political leadership actually chair the TRAC. And is that going to then be leading into chairing any other, sort of, spinoff of TRAC? And we would like to hear anything on those issues, too.

MS. MULKEY: All right. Well, thank you. Well, with that -- and hopefully you've marshalled your thoughts, and we would like to hear your feedback and your recommendations on this set of issues -- how we operate, how we -- how work groups operate, membership issues.

UNIDENTIFIED MALE: Length of meetings.

MS. MULKEY: No breaking and lengths of meetings, way in which meetings are conducted.

UNIDENTIFIED MALE: Quality of the sound system.

MS. MULKEY: I'll give everybody a chance to take a deep breath, and we'll see if we can get some sense of who wants to engage on this. Okay, Larry, why don't we start with you?

MR. ELWORTH: Well, I really would be interested in how other people feel about the way work group products are represented. I, for one, don't think that we've come together to develop some consensus recommendations.

Some others of us were on the eco-standards work group -- does three concurrences mean that PPDC concurs with the work group product? Does it mean we don't -- the PPDC doesn't concur with the work group product?

For my money, I am glad to have these work groups operate to present information to the Agency. With or without the concurrence of the entire committee, the advice can be considered by the Agency or not considered by the Agency.

And my other concern in this has been if an issue is raised for my concurrence or nonconcurrence, I feel a different responsibility than just having a report made available to the Agency for discussion or consideration.

So, to my knowledge, while I was glad for the Inerts group to have presented their thing yesterday, I was surprised that then I was asked to endorse or not endorse their proposal. I mean, it's perfectly fine information, glad they worked hard and everything.

So, I actually would be interested in what other people think about how we ought to operate.

MS. MULKEY: Ken, I suspect your flag went up on that topic, so while Beth's was up earlier, maybe for continuity, we can do that.

MS. MARSHALL: I suspect we're on the same topic.

MS. MULKEY: Oh, all right, fine. Then by all means, go ahead, Beth.

MS. MARSHALL: I also served on the -- on a work group with Larry, whose report was discussed, and with Steve and Ken.

I was a little surprised, actually, to hear Larry say that he didn't feel he had had an opportunity to consider the work group findings and was surprised that he didn't comment on them when he was given the opportunity.

I think when you're dealing with a work group, transparency, and operating in the open, and taking part in discussions are all very important.

And the things I liked about the two work groups I've been on is that they involved the general public. Their meetings were open to the public. Minutes of those meetings were provided to all work group members -- very detailed minutes even -- which certainly helped the members of the group -- work groups who weren't able to attend some of the meetings and some of the discussions.

And then, the report was circulated throughout the entire committee, which I think is perfectly appropriate and should be done ahead of time --



-- and the second opportunity to comment on the report -- to take part in agreement or non-agreement with the report after the meeting.

I think that's all very appropriate. I think in an ideal world you want to have everybody's comments. But it did surprise me to hear Larry say that he didn't feel he had the opportunity to comment. You did.

MR. ELWORTH: No, that's really -- I wasn't concerned about the committee process. My question is a more procedural one as to how the PPDC wants to operate. Do we want to regularly endorse in consensus -- endorsement of a particular report? Or are we just comfortable with the report being presented and whether -- not so much on that work group, but on other work groups, if we're to come to a consensus on an issue, and then make a recommendation to the Agency, that's one thing.

To have a report go forward with some recommendations in it from the committee with or without this group's consensus is the issue I'm raising.

I'm comfortable either way. I'm just asking how people feel about it because we seem to have two or three different ways of going about it.

One is we're asked to endorse, the other is something said for concurrence. Lots of other work groups have reported without that kind -- is basically giving a report.

So, I'm just asking how people want to go about it. Whether we want to have some procedures, or whether we're comfortable just on a case-by-case basis dealing with it.

MS. MARSHALL: Well, I believe we did follow the procedure which had been laid out for us.

MR. ELWORTH: I'm not -- okay.

MS. MARSHALL: And, therefore, in this case, at least, since the committee was, in fact, given the opportunity to comment, to disagree or not to disagree. And three of us chose to comment, the rest chose not to. That would certainly imply that nobody felt strongly enough about it to disagree. And thus, it seems to me that it is a valid statement of what this committee thought should be done.

MS. MULKEY: It might be helpful if we note that advisory committees don't have to reach consensus -- give their advice by consensus. And there may be some sense that -- there may be some times when they want to -- when they think that the achievement of a consensus is particularly compelling, will enhance the likelihood the Agency will adopt the advice.

And so, maybe part of the difficulty here is the question of, is it important? I mean, is it important that this product -- that is, the work group's product -- be seen as something that is -- the consensus position of this advisory committee?

Or is it sufficient to represent what it is vis-a-vis the work group -- which I think in that instance was a consensus or some kind of compromise conclusion of the work group, which carries whatever weight that carries, which in the case of some of these work groups may carry more weight than consensus than this advisory committee did depending on the subject and the expertise represented, you know, in the work group, and so forth.

So, that may be the hang-up is that -- at least that's sort of where I sense Larry was coming from. It didn't seem to be about not liking that report, or not wanting to be characterized as agreeing or disagreeing.

It was more like a more complex -- and in some ways a simpler question having to do with, sort of, what does it mean that you have a work group report? What does it mean vis-a-vis the point of view of this organization? Does -- is the only next step to try to get this organization to embrace it as a consensus position?

Legally, I'm pretty sure we will confirm this, but I'm pretty sure that's not the only available option.

MS. MARSHALL: In the case of that particular work group, it seemed to me our rules -- the rules in which we agreed to operate -- were always that our report would come back to the full committee.

The full committee would be given an opportunity to comment on it, to agree or disagree. And had the full committee said, no, we don't agree with these conclusions -- or a majority of the full committee had said, we don't agree with those conclusions, probably that report would have been substantially changed.

MS. MULKEY: But wouldn't the committee have also had the option of, we're happy to have this report go to the Agency as it is without, quote, agreeing? I guess that's the question that's on the table. Neither agreeing nor disagreeing, I guess, is what that amounts to.

MS. MARSHALL: Right. I think -- I feel it fairly strongly that the full committee should have the opportunity to look at the reports of work groups -- of all the work groups and provide comments.

MS. MULKEY: Oh, I think you have to do that, I think, in order to be a part of the advisory committee.

MS. MARSHALL: And if the full committee doesn't agree, then I think probably the report needs to be worked on just because I think a work group is a subcommittee. It's not a stand-alone group, and I don't think it should be.

However, when the larger committee chooses not to comment one way or the other, I think you have to assume that the report should stand. And, you know, the committee has been given its opportunity and has spoken by not doing anything.

MS. MULKEY: I think the question is, does that mean that the full committee agrees with every word in the report? Does it mean that it agrees that the report should go forward as advice to the Agency?

MS. MARSHALL: Mm-hmm. I --

MS. MULKEY: Kevin, maybe you can help us out here.

MS. MARSHALL: I don't think that -- I would be amazed if there was any report in which the full group agreed with every word.

MS. MULKEY: Right.

MS. MARSHALL: Or -- but I think that if there are no objections, that, indeed, it should be accepted as advice to the Agency.

MS. MULKEY: Okay -- (inaudible).

UNIDENTIFIED MALE: Well, first a question. What would be the difference in effect to the Agency between a report endorsed by the full committee and a working group report?

MS. MULKEY: Well, as I said, I think the working group report has to come to the committee just legally for it to be, sort of, the rules of the game of the advisory committee. It has to come to the full committee, they have to have awareness of it, they have to have an opportunity to overlay their perspective on it.

But assuming you, sort of, touched base with the legal, I don't think there would be any difference. I mean, the difference is the weight of whose views are being reflected, how -- what they say, what they represent.

UNIDENTIFIED MALE: Well, just some observations. Knowing the people in the process of the work group, that wasn't the consensus report in the sense that we all came to one mind. There were compromises made in that report.

I certainly wouldn't expect this group of people to agree on many things. I think the rodenticide group is really lucky to hit consensus. And the things that -- when we do reach consensus, it will either be an amazing news story or completely trivial depending on the circumstances.

The one thing that I wouldn't want the process to entail would be to allow things to come up to the committee, for people to object, and for that to bottle up a report unless the specific grounds of the objection were made clear.

Where we were at the end of the meeting at the beginning of the year with just, sort of, unspecified objections on the table freezing the process, kind of bothered me.

Now that we've given people an opportunity to specify their objection, in fact, in the formal process they haven't. Now that there's still actually an opportunity for anyone, in fact, in this audience who might have concerns about the subject -- the working group report to voice those in -- not voice those in writing -- but to express those in writing and send them in to the Agency.

I think we should -- at this point we should push through -- you know, push the report on to the people in the Agency who can do something about it, who can respond to it, and just let it go at that.

MS. MULKEY: I think we can declare that as having happened unless somebody objects.

UNIDENTIFIED MALE: Okay, because I -- at this point, we're never going to -- we would take up hours in the full committee debating fine points of the report. We're never going to get everyone to actively support it. We have everyone passively supporting it at this point, I guess, because we had no objections to it in the formal written review.

I think if we try -- I suspect -- correct me if I'm wrong -- that if we did what we did at the end of last session and asked, are there objections at this point, we would get objections. We would get people who would be uncomfortable endorsing the report.

So, at this point I don't think there's much more that we can do. In the future, again, I strongly urge anyone who has objections to make those objections clear and explain them to other members of the committee. And if they're strong enough objections, then I think Beth is right, we should send things back to the work group for reworking.

MS. MULKEY: I think what you've -- I believe -- in fact, I'll even try it. Does anybody want to express an objection to having the work group report we're talking about now -- is the ecological work group -- are there any objections to the Agency receiving that advice now from that work group having -- its having been vented as opposed to endorsed by this committee?

Well, I think maybe we do have movement on that. Bill.

BILL: Yeah, I have -- have we finished with the eco -- (inaudible) -- work group?

MS. MULKEY: I think so.

BILL: I want to build a little bit on what Larry was talking about. As a new member who has been here a year-and-a-half, I still think there is room for role clarification.

I mean, I enjoy coming to these things, I get a lot of information, and it's quality information, but I'm not sure beyond my be here now response to what's presented -- I don't know what other kind of expectations or depth of commitment you're really wanting out of PPDC members.

And I feel like I would like to be more involved somehow, but I don't think I'm being asked to. I mean, I don't understand really what you want out of us beyond sitting here and responding to a particular presentation.

So, if that's -- if that is the extent of what your expectations are great. If you're wanting more that would be nice to know.

In regard to coming here and endorsing a particular position -- if we're being asked to do that, I think it's very important to let us know that ahead of time and really give us the opportunity to -- if we're being asked to endorse a recommendation, that there is something sent prior to three days before we're showing up at the meeting -- the information, the expectations so that we can seriously endorse it or let it happen.

So, those are my two points. I think a final one is, my sense is that when we're receiving technical presentations, I was perfectly fine because of my background to listen to the MOE discussions and the risk assessment things. I'm not sure that everybody here would even understand everything that was presented and could comment on it in a knowledgeable way.

So, we may want to in those cases take the temperature of the room and find out what kinds of level of presentation should be made because it may be over some people's head.

MS. MULKEY: On your first point, what do you think our expectations of you ought to be and the role we ought to be having you play?

BILL: Well, I think each of us comes here from a job where -- and a particular point of view, and I think as I've seen this, we all tend to comment within our area of expertise.

I know that some people feel like they shouldn't comment in areas outside their area of expertise, so we tend to be kind of siloed in what we talked about. It might be useful to know if you want us to be commenting on -- in a broader context. I --

MS. MULKEY: I think we should be inviting you to play in any of the issues that -- do you think -- (inaudible)?

BILL: Well, that might -- and that might be something that is stated.


BILL: You know, just simply stated so that people feel like if they want to comment on worker protection even though they don't have anything to do with that, encourage them to do so.

It might not be something that people feel. I also feel like it would be great if you would ask more of us in some way. I mean, if this is an important committee for you, then give us something to do between the three or four months that we meet besides work group activity, which I think is really valuable. I'm seeing that as an emerging true value of this committee.

But the members sitting around, if you want us to be working an issue, I think somebody would need to -- at the Agency would need to be coordinating and pushing us to work a particular issue.

Like, I got your report -- I didn't really get a sense of my own need to weigh in on it. You know, I'm sitting here silently agreeing to something that I didn't read. I don't know how many other people failed to read it, also.

Maybe there needs to be a set of expectations that, hey, if you get one of these things, and we're going to talk about it, and we're going to pass at the meeting, you ought to read it. I mean, I know that sounds stupid, but set those expectations for the committee and, sort of, demand of us that kind of degree of participation, I guess.

MS. MULKEY: We don't want to lose Jose's suggestion that we said we would come back to, which was essentially that -- let's -- as I took it, he was saying, let's a group of us take on ourselves a sort of a microcosm of this issue of the worker protection rule and other in-field worker protection issues.

And that's -- I mean, that's something we could broker happening, that's something one of you could take the lead on. That's, I take it, the kind of thing you have in mind.

BILL: Yeah, it is. Although when Jose was talking, I thought, well, this sounds like a new work group, and then everybody thought, no, I don't want to be that formal.

So, if it's not a work group and it's something else, that's good, though. You know, let's go to work.

MS. MULKEY: Well, we would obviously have to learn how to make something else work. Shelley.

MS. DAVIS: Well, as a sometimes member of this group, I think that the point of this is not to be a consensus body. I think the point is to represent whatever segment of the community affected by pesticides you do come from and express that view.

And speaking for the worker side as an example, I mean, I -- we're not a majority here, and I'm not really trying to convince you all, and I don't feel obligated to.

So, I really feel like the important aspect is to provide the Agency the advice that you think is relevant from the segment that you do come from.

That said, I think that there is also value in, kind of, continuity. I think sometimes it is frustrating that something comes up, and, you know, a point of view or a report is made, and that is kind of it.

And there are issues that need follow-up, and I certainly think, you know, Jose's idea or other people's ideas on following up on the worker protection one is a good one because that's a big issue and probably can't be addressed adequately even in the lengthy time that was given here today.

So, you know, I think that that kind of thing is good, but I don't think that the work groups should have the expectation of a consensus report or approval by the committee because I don't think that's really the point of this committee.

MS. MULKEY: Okay, thank you. Dan.

MR. BOTTS: As a charter member of this illustrious group going back to the creation and then the closing of the government for the first six months of its existence so we didn't meet, I have to reiterate or build on something that Larry brought to the table.

And I -- it was my understanding when this group was created, formed, it's a dialogue committee. It was not designed to be a consensus-building organization. It was a way to get a diverse group of people that have a stakeholder interest in the programs of the Agency to come together, have information provided to them to discuss in a forum that everybody was sitting at the same table at the same time to be able to bring back.

As the program has evolved, there were work group issues that were put on the table either at the specific request of the Agency, or because of interest by the participants in the work group, or in the committee itself to bring issues to a higher level of discussion.

And there have been at least four or five different processes associated with how those work groups function, how the results were brought forward to the Agency, whether -- how they were addressed by the Agency, whether the work groups even reached completion of their group.

And I think to build on a little bit of the frustration that Larry brought forward -- not only specific work group function, but we need to have some kind of definition around what the expectations are if we're going to put the time and effort into those kind of work group functions.

Is it to go to a consensus document? Is it to provide additional information to the Agency? Are there time lines around these processes because a lot of them which have had time lines around them, you reach the end of it, you present something, and then it's like it's gone away, and you don't get any results back.

And specifically on the eco -- (inaudible) -- process, I mean -- going back to the old SEETAC (phonetic) committee that a lot of this stuff was built out of back even before this group was created -- looking at how they looked at ecological impacts in the group, and I have to admit the same level of scrutiny of this report.

I received it, I noticed I had a time line and a deadline, but because of other responsibilities, it got buried on my desk. And when I found it again, it was after the deadline for response.

But knowing that the proposals -- some of the proposals that are contained in that report have gone to the Science Advisory Panel for more elucidation, discussion. I felt that this report was, essentially, building on something that the Agency wanted to educate us about and didn't really require direct input or recommendation from us to go back.

If that's specifically what we want to do, we need to know that as a group, and we need to have that defined and put in front of us when the process starts, rather than wait until the very end of the process.

MS. MULKEY: Thank you. Any of you -- I'll call on you in just a minute -- but any of you want to speak to these questions that Jim posed, sort of, about -- as I took it -- content, conduct, mood, level of visibility, level of Agency participation -- any of those issues as part of this? And since Beth had her flag up before I asked that question, we'll call on her and Bob.

MS. MARSHALL: Well, the two work groups I've been on -- one was the ecological standards group, one was the infamous brochure committee -- you had very different goals.

The brochure committee had a very specific task. It had to do with a specific deadline, had to produce this brochure, had to do it within a certain time line for a particular audience.

And I think the committee was heavily involved -- the full committee was heavily involved in comments on that brochure. It was in some ways considerably easier because it was so specific and so concrete.

The second work group was the ecological standards group in which we were asked to evaluate the Agency's current process -- to take a look at the Agency's current process and make some recommendations about changing that process, or if we thought it should be changed.

And, of course, there were numerous viewpoints on that committee -- some of whom didn't want to see any changes, and some of whom wanted to see vast changes.

I'm not sure we ever said that we wanted to have a consensus report, but we did want to see if there was a way that we could come to some general agreement within the committee, and then present the report to the overall committee to see if they agreed with that.

It was -- there was a different goal and a much less concrete goal. So, I suppose what has happened in the two committees I've been on is that they each came up with a different process based on what the goal was.

MS. MULKEY: And maybe that's what I was looking to make sense. Bob.

BOB: Well, just to kind of change the subject -- maybe go back to something Jim said, which is -- relates to the question of the composition and the focus of the committee.

Presumably, TRAC meets in October, and then this group is going to, I assume, meet sometime after that. And if that's true, and if it's true that there is not going to be a TRAC after October -- and I guess I should go back one step and say there are actually some of us who think TRAC was a pretty good process. You know, which is, I know, not a universally shared point of view, but some of us did think it was valuable.

My point is that if this committee becomes a son-of-TRAC or becomes the only venue for which -- yeah -- stakeholders have input into the FQPA implementation process, then it strikes me that the, a, the composition and the focus of this committee changes fairly radically, at least for the short run; and -- or at least I would hope that was the case.

I mean, I, frankly, if there was no other stakeholder process for vetting or discussing FQPA, and this was that only process, I would, frankly, you know, hate to spend time talking about a lot of the kind of stuff we talked about these two days when there were FQPA issues that weren't being discussed elsewhere.

So, having said that, if there's not going to be a TRAC, I think this committee ought to look a little bit like what TRAC has looked like, at least for the immediate future.

MS. MULKEY: Do you think it's okay that then the kind of thing this committee has been tackling would go untackled?

BILL: Well, no, no, no, no. You know, gosh, I knew you would say that, and I think this is valuable stuff, but something that has always troubled me about this committee has been that this is kind of like the piano player on the Titanic. These are important issues, but FQPA is out there, and it's sometimes hard to think about some of these issues while that's unresolved.

UNIDENTIFIED MALE: Which one is the piano?

BILL: Huh?

UNIDENTIFIED MALE: Which one is the piano?

BILL: I think these are all important issues, and there is probably a lot more important issues that could be tackled. I just think that because of its prominence as an issue that FQPA will at least for the foreseeable future remain the premiere issue.

And as long as this is the group which is going to be the principal source of input on FQPA, I would expect that that's the thing which, I mean, poll the committee, I don't know. I would guess most members of the committee would probably share the view that they would want that opportunity and that focus.

UNIDENTIFIED MALE: All right. Again, I think you may have had suggestions about either meeting frequency or duration of meetings. Obviously, there are limits to both of those in terms of schedule and your own desire to listen to us, and vice versa, and things.

So, I mean, there's -- but I mean, it is always a question of how do you choose your agenda because there's always lots of different issues.

We have 1,000 people working on a very complex subject, you know, 365 days a year, and obviously big things are at stake -- you know, the food and -- (inaudible) -- production, the thousands of people who work in the industry, millions of people exposed to the, you know, so we could really spend all of our time meeting and not working.

But, you know, so, you have to realize that you always have to choose among your agenda items and everything else. And any input on that would be helpful, too.

So, for example, something more regularized -- every six months. Well, if you're going to do a lot more subjects, you should meet quarterly. Well, and by the way, any meeting longer than a day-and-a-half I really can't come -- I mean, any real specific mechanical kind of recommendations, too, as we go further would be helpful.

MS. MULKEY: (Inaudible).

UNIDENTIFIED MALE: I wanted to comment on the meeting process a little bit. When we first came to these meetings, I really felt that the Agency talked too much, and there was no dialogue. And I think over the last three years or so that's changed, and I give the Agency a lot of credit.

I think that your staff comes prepared to talk about the issues, and then they listen. And I think it's this format that allows for a dialogue, and I think that's important.

I don't know how to answer the FQPA question. We started talking about some of those issues. That's such a complicated issue you could probably have 10 advisory groups on it and not deal with all of the issues. So, I think that's something the Agency will have to figure out.

MS. MULKEY: Theresa.

MS. MURTAGH: Just a note on composition of the group. If FQPA and TRAC-type issues do come to PPDC, I think we should look at the membership of the group, which you were suggesting, to include additional grower and agricultural representatives, the growers, the commodity groups, additional land grant university representatives.

I know CROP consultants made an excellent contribution to the TRAC discussions, too, and I think that would be another group to consider adding.

MS. MULKEY: How did you think about doing that and keep it -- would you then just expand size in order to do that?

MS. MURTAGH: I think it would have to grow. I know that that's troublesome. This certainly is a group whose discussions were a lot -- it was a lot more interactive than TRAC where you had your -- I have to pick words very carefully when you talk about TRAC, but the group was just, by far, too large. For what? I don't know.

MS. MULKEY: Okay. Anything else you want to share?

MS. MURTAGH: I just wanted to make the note about the composition.

MS. MULKEY: Okay. Jacqueline.

MS. HAMILTON: Well, I think that the length of meetings is about right. Day-and-a-half is doable even in the middle of a busy season.

I would recommend that -- I don't know if this is a problem for anyone else, but when you have overlapping meetings as we do now between PPDC, and the SAP, and other things that we're involved in. There's an EPA-sponsored two-day water meeting going on now on drinking water safety.

When they all overlap and take place within the space of the same three or four days, that certainly causes us some resource problems. So, if there can be any effort to coordinate when those meetings happen so that there is not quite so much of a direct overlap between three different things, all of which are related, that would be helpful to us.

I think one of the strengths of the PPDC all along has been -- it's my impression, obviously, -- I'm sitting in for someone, so I have not participated throughout the length of time of this committee.

But it is my impression from talking to Erik Olson and others that one of the strengths of the PPDC is its size. You can actually have a discussion, have everyone feel as though they've had their say, and move through issues in a reasonably expeditious fashion.

That was one of the big problems with TRAC. It's -- when you've got such a huge group, you take a whole day to get through, sometimes, one or two issues.

The composition seems roughly right to me. Obviously, you can always tweak these things, and it always depends on what issues are coming up. I -- we felt that the TRAC was highly imbalanced. And so, to change the membership of this group to more reflect what happened in that group, I think would weaken the strength of this group. So, I have some, sort of, not very happy feeling about all of that.

And in terms of work groups, I think actually what Marcia was proposing toward the end and what wound up happening with the eco-fates group, unless there is some specific reason to do it differently that we might consider generally saying PPDC should have an opportunity to comment, should have the documents, should have them with enough time to review them. Clearly, we had ample opportunity in those previous examples.

And then it would be passed on to the Agency as something that PPDC acquiesces to as opposed to actively endorsing.

UNIDENTIFIED FEMALE: Marcia, just one more note about size. Going back to the TRAC, the TRAC work groups did work well together. They were small in size.

MS. MULKEY: It was approximately half the larger group.

UNIDENTIFIED FEMALE: Yeah, that did work.

MS. MULKEY: Well, one of the things -- you were talking about membership. I have sensed in this group pretty constrained representation of people who actually farm.

We had -- basically, we were down to Bill today. And now, Dave did a great job of representing, you know, the potato folks and -- but he doesn't actually farm and our regular member does.

And so, I have -- I think we need to think about not only where the balance is, but, sort of, who is here representing a point of view.

I think, for example, the fact that Paula works for one company gives us something that Jay can't give us. On the other hand, you wouldn't want just one company's point of view at the table.

So, I think there are -- in my view, and I'm wondering if you guys have any insights in, sort of, how to keep the numbers down and find the way to have the points of view at the table that really add to the mix.

On the other hand, if you just have people who farm one or two commodities, you lose the kind of thing that Dan brings to the table, which is, you know, a breadth of commodities, a whole state's experience.

So, it's a real tough thing, I think, to try to figure out how to get all those points of view here without 50-some-odd people. So, if you have any thoughts about that. Jose.

MR. AMADOR: Well, I try not to repeat what other people have said, but when I first was invited to join this group, my understanding was -- and remains to this day -- that, you know, you are the people who set the agenda. I mean, we are here to advise you and to give you comment.

We're not here to tell you how to do things. We're not here to set policy. We don't have any of that prerogative.

So, you're the one that has to tell us, you know, what are some of the issues that you think we ought to be prepared to discuss when we go into the TRAC -- I mean, when we come to the meeting here.

Now, TRAC got us off the track of this committee. You know, we got to do something else. But the first few meetings that we had before we had the FQPA, was basically that. You know, just together, give us agenda, and listen to what we have to say.

We don't have to reach consensus. We don't have to agree as a group and tell you this is the way that this committee is going to present the views. I mean, this is just questions of opinion.

As far as the size is concerned, I think that I agree with the reason in a way, but if we get too big, we're going to lose some of the things that we now have, which is the ability for everybody to participate in the meeting.

We have people here that have multiple abilities. I guess I represent the extreme -- (inaudible) -- extension service to -- (inaudible) -- but we farm, too. I have about 600 acres that I need to farm, and I will farm citrus, and vegetables, and sugarcane, and cotton, and -- (inaudible).

MS. MULKEY: Fair enough.

MR. AMADOR: As a matter of fact, my cotton is being ruined right now by all the rain that we're getting, and that's going to be a lot of rain coming to the station. But -- and I appreciate that everybody here has things, you know, other things.

But the main thing that we have to keep in mind if we change our charter is we're here to advise you. You tell us what is the topic you want. I mean, I really appreciate you asking for topics. You did ask for topics. I suggested some. It's nice to have that.

But in the final analysis, I mean, we're here to advise you, and to give you comment, and for you to do then whatever you think is best. It's not for us to tell people how they ought to do things.

MS. MULKEY: Paula.

MS. PAUL: You know, some of the evolution of this committee, I think, it evolved out of part -- partially, anyway, out of meetings that the industry used to have quarterly meetings with Dan Barolo. And it was his sense, or his desire, that he liked those meetings, but would have liked those to be broader -- where we would bring our issues and our comments on pesticide programs to him.

And this was -- he said he also -- it was good for him, and he also wanted to be able to get the same feedback from a broader representation of the industry, which I think is good.

So, you know, to the extent that we used to really focus probably more carefully on the agenda than what we do now and maybe we need as an industry to think a little bit more about that.

But it does change the dynamics a little bit in the discussions because some of the things that are of primary concern to us like registration backlogs and time from submission to registration probably, you know, other people around this table might not really care as much about that.

But I think it is a good process. It probably would be helpful to focus the discussion by, maybe, posing questions or particular issues that are troubling you if there are places that you want us to focus our feedback that might be a little bit helpful.

UNIDENTIFIED MALE: One other comment to something you said, Paula, made me thing of this. The other thing is that this is not the only venue and the only forum for advice, information, comment, et cetera. So, I think as we go forward, it's something we struggled with, again, in the, sort of, larger subject of not only this particular group, but TRAC and son-of-TRAC, or whatever -- is what are the number of opportunities, and ways, and methods, and sort of conventions that anybody might want to suggest?

For example, if those, sort of, more specific to a constituency group interest -- subjects of interest might be done by a quarterly meeting. It would be public perhaps, but obviously most of the people who are going to show up about the registration time frame discussion are probably going to be you, and that's fine.

Similarly, for other folks -- whether there be, sort of, again, a some kind of every-so-often -- whatever that metric is -- follow up on whatever subject -- on minor use issues is certainly one that we always constantly struggle with.

On latest advances in the science assessment arena, sort of separate from any big thing -- just sort of just generally, what have you guys been doing lately? What are the cutting edge issues because not everybody might have attended every SAP meeting, and things like that.

I mean, again, we're open to all kinds of suggestions in terms of form, format, frequency, and all the rest. And that's -- that as you get back to us on this particular, quote, subject, about this committee, I think all those other things are within bounds, too.

MS. PAUL: Yeah. You know, from time-to-time, the Agency has done some workshops on specific issues. I think there was one on residue. I know the residue, a dietary assessment program. There have been a variety of them.

But those kinds of things, I think are good for the Agency because to have a forum where people can stand up and really show what they're doing and explain to the public how they're going about a risk assessment, I think is a good thing in the broader -- the more breadth you can get of exposure you can get -- public exposure, I think that's good.

And feedback -- some of these workshops gave some good opportunities for feedback dealing with particular issues, too. So, it's another, you know, another way of approaching the same thing.

MS. MULKEY: Well, we are, I think, at this point slightly past our time, but we will call on Ken, and then we'll try to have a quick wrap-up.

MR. ROSENBAUM: Just yesterday you mentioned the dormant working groups, and -- at least the Gippert (phonetic) group, I think the reason it's dormant is because the chair has never called it back into session. And it serves at the pleasure, basically, of EPA, and if you think that's important, then I bet the group members would be happy to come back to it.

MS. MULKEY: Well, thank you. Well, because we have a rechartering to go through and because -- and therefore, a membership approach completely independent of this question of whether and to what extent this charter and this forum tackles -- becomes the only key stakeholder group tackling FQPA.

And that, of course, raises questions about the Department of Agriculture, which as you know is a co-convener of the TRAC; and they are, of course, a robust member of this group.

But there would be some -- some meaningful change in that dynamic, among others. It is a little difficult, I think, for us to look forward to the next meeting even as much as we were able to last January.

And what we did try to do last January was to begin to adapt to your thinking about how we should be building agendas, how we should be interacting.

And we can try to take some of these things that you said. And I think we're probably going to have to start with our first meeting in whatever new incarnation this entity has to begin to tackle those issues -- hopefully, not without regard at all to what has gone before. But it's hard to commit now to, sort of, planning for the next one.

Having said that, I would like to commit -- if -- unless somebody tells me you think that it's appropriate -- that Anne and her team will explore with, at least, Jose and Nelson and whoever else they tell us had this informal interest in this Texas-based effort regarding the worker protection rule -- to at least explore that idea a little bit so that we don't just let it lie with, you know, without any -- I don't know how practical it is, how it fits with other kinds of things that are going on, how we would latch it to this committee, if at all.

But it does seem to be that we shouldn't just walk away without committing to take some further look at that. And it's a shame that George is not Region VI at this moment because it would be nice to have some of the key players here today.

MR. PAVLOU: I would like to be able to do that.

MS. MULKEY: But those are the kind of folks we would obviously want to explore the state -- some others. Without that, does anybody think there is anything we need to cover before we -- I suppose to some extent, this adjournment has some symbolic significance since it's the end of this committee's charter.

It has been my pleasure to be a part of this. It was something that was built for the program at the time it was originally built. It sort of interacted with the program, and it has been very beneficial to me in my efforts to play a role at the program level as a program director.

And if it does take on a permutation that alters that dynamic in some significant way -- obviously, we pay very -- as a program, we are intimately involved in what TRAC handled.

But we do benefit, I think, from a balanced perspective on a wide range of program issues. So, we would be seeking out you and folks like you in some effective way, I hope, regardless of what happens regarding the rechartering. Yes, Phil.

MR. BENEDICT: I would just like to take a moment and thank the Agency, and particularly Margie for what she has done for the last two or three years in making this thing work -- and her staff.

She has, kind of, kept us on target, and she has provided us what have needed to get here and everything else, and I think that's real important, and that's what makes these things function.

MS. MULKEY: You bet. There's no question this wouldn't happen at all, let alone happen reasonably well. And the reason is all Margie, and my heartfelt thanks to her. Do you have anything you want to say as we close down?

UNIDENTIFIED MALE: No, just thanks for everybody for coming and taking time, and we'll, you know, just -- we'll probably see -- whether we want to or not -- all of you in other capacities, whether it be this one or otherwise, so --


UNIDENTIFIED MALE: We would have to invent you if you didn't exist.

(Whereupon, the meeting was concluded).

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